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- 2026-05-02 10:21:18
- Opinion
- [Reporter's View] The reality of drug shortage reports
- by Lee, Hye-Kyung Nov 14, 2024 05:52am
- Reports of shortages of oxytocin, an injectable drug used primarily as a labor inducer, have caused confusion in the obstetrics and gynecology field. Most obstetrics and gynecology centers that have a large number of expectant mother visits stock enough oxytocin to last 2-3 weeks, but JW Pharmaceuticals, which holds more than 70% of the prescription market, has announced a shortage of its oxytocin supply that will last until January next year. In the case of childbirth, there is no reason for a sudden surge in a drug’s demand like infectious diseases or colds, but oxytocin is designated as a national essential medicine that must ensure a stable supply as it is used to induce labor in mothers. In Korea, only two companies, JW Pharmaceutical and Yuhan Corp, manufacture oxytocin drugs. Since it is a national essential medicine with a small number of manufacturers, it seemed natural that supply and demand management would be in place, but out of the blue, the clinics and hospitals were suddenly just told that “there was no medicine.” A small hospital in a rural area with a low birth rate would have ordered the medicine on a case-by-case basis rather than keep two to three weeks' worth on hand, so the news that it would soon be out of stock must have been like a bolt from the blue. The question that first came to mind was, why is there a national essential medicine system in place if it cannot manage the supply of essential drugs? When looking closer into the situation, the cause was clear: the system was not well established enough to ensure a stable supply of the necessary drugs. The discontinuation of the manufacture, import, and supply of finished drugs must be reported to the Ministry of Food and Drug Safety 60 days before the discontinuation date. However, as the criteria for reporting shortages are set differently in each company's SOP, and there is no absolute threshold set for determining drug shortages. In the case of oxytocin, the MFDS was able to identify the shortage only after looking into Yuhan Corp’s shortage report, a company that only accounts for about 30% of the oxytocin market share. On October 28, the company reported a shortage of oxytocin on the market, stating, “There is also supply disruption for Choongwae Oxytocin Inj.. which is approved with the same ingredient. With no substitute drug available containing the same ingredient, a supply shortage is expected for a period of time, but we will be able to ensure supply from November 14, 2024.” Up until this point, JW Pharmaceutical had not notified the MFDS of its shortage. The problem was that the MFDS was not informed, but the letter sent to obstetrics and gynecology clinics and wholesalers indicated that the drug would be “out of stock until January.” Even if the drug is designated as a national essential medicine, the KFDA cannot know about the shortage without a report from the pharmaceutical company. The MFDS began to investigate the situation when it learned about JW Pharmaceutical’s oxytocin shortage via Yuhan Corp’s supply shortage report. JW Pharmaceutical, which has a higher market share, was unable to manufacture finished drugs due to issues with the API, and the MFDS reportedly supported the necessary measures and moved up the manufacturing date from January next year to December this year. This situation seems to have occurred because the threshold for shortages was not specified. Each company had a different threshold set for sending “out of stock” reports to the MFDS. Yuhan Corp reported a shortage when it crossed its threshold of shipments this year, while JW Pharmaceuticals did not report a shortage until it was likely to run out on site. It's not easy for the MFDS to keep track of the shortages of more than 500 national essential medicines every day. Unless the ministry receives a proper report, they cannot provide the necessary support, but if the product becomes out of stock even before the ministry can consider support, there is no opportunity for the authorities to take action. As a result, no medicine is available on site, with the government ending up taking countermeasures after the damage is made. Last year, the Ministry of Food and Drug Safety revised the Ordinance of the Prime Minister to pull forward the drug shortage report from 60 days to 180 days, with implementation scheduled for April next year. However, if the regulation is revised without a baseline for reporting not established, cases like oxytocin will only repeat itself. We need a system to address stockouts before there is “no medicine” on site.
- Company
- Lee Hyun-ju named as the representative of ZP Therapeutics
- by Eo, Yun-Ho Nov 14, 2024 05:52am
- Lee Hyun-ju, new representative of ZP Therapeutics Korea Lee Hyun-ju (48), ex-Daiichi Sankyo Korea's Oncology Business Franchise Head, was appointed as the new representative of ZP Therapeutics Korea. Industry sources said Zuellig Pharma has recruited Lee Hyun-ju as the new head of ZP Therapeutics Korea, Zuellig Pharma's commercial services corporation. Lee holds a degree from Sungkyunkwan University's College of Pharmacy, and she has years of experience in the Korean pharmaceutical market with expertise in the anticancer business. Lee started her career in 1999, undertook roles in Handok's marketing and Sanofi's marketing, and worked as Roche Korea's Oncology Cluster Lead and Novartis Korea's Hematology Cluster Lead. Lee moved to Daiichi Sankyo's Oncology Cluster last year and served her role until the new appointment. Meanwhile, ZP Therapeutics Korea is committed to providing a comprehensive solution, encompassing marketing, sales promotion, product launch medical e-detailing, registration & approval, market access, digitalization & data analysis-based sales excellence, adapting needs and changes of the pharmaceutical market. ZP Therapeutics Korea established itself as a commercial solution partner sought by pharmaceutical clients. The company is involved in in-licensing of many prescription drugs and over-the-counter (OTC) drug brands. ZP Therapeutics Korea also provides sales & marketing services, supporting major pharmaceutical companies.
- Company
- Celltrion anticipates Trump admin will bring positive shift
- by Whang, byung-woo Nov 14, 2024 05:51am
- Celltrion anticipates that President-elect Donald Trump's second administration in the United States will positively affect the company's biosimilars and Contract Development and Management Operations (CDMO) services. On November 12, Celltrion presented stockholders with the potential impact on the business under the title 'The Business Impact and Outlook upon President-elect Donald Trump's second administration in the United States launches.' Celltrion cited a report from the Korea Institute for Industrial Economics and Trade, 'The potential impacts of the U.S. presidential election on Korean industry and outlook,' and analyzed that the Trump administration will be friendly towards using generics and biosimilars. Currently, healthcare expenditures in the United States accounted for 17.6% of the country's GDP in 2023. As a solution, Trump's first administration implemented initiatives such as the 'Lowering Drug Prices by Putting America First' administrative orders and the 'American Patients First' plan to lower drug prices. These policies include details regarding biosimilars, including 'Improve Competition' and 'Lowering List Prices.' "When President-elect Trump's second administration launches, the administration is expected to take over the policy during the first administration and pursue healthcare policy," Celltrion said. "We expect the administration will favor expanding biosimilar prescriptions, which is Celltrion's main business." Trump's first administration pursued a policy of regulating drug pricing, proposing a bill to Congress to stop pharmaceutical companies from paying rebates to the top 3 pharmacy benefit managers (PBMs) in the United States. Such a move was said to be friendly to the biosimilar market. Additionally, as the administration pursues the PVM reform to alleviate financial loss, a by-product of economic stimulation, by reducing taxes, implementing a policy that expands the use of biosimilars is expected. Such a move is expected to be favorable to Celltrion. In particular, Celltrion anticipated these policies would positively impact its CDMO service, which will be Celltrion's growth momentum. The 'Biosecure Act' bill, the U.S. Congress initiative, 'prohibits entities that receive federal funds from using biotechnology from a biotechnology company of concern may not contract with any entities that do so.' The Biosecure Act is expected to support establishing a new supply network in US-friendly countries with business competitiveness, including South Korea, Japan, and India. "In line with the U.S. industry trend, we will complete establishing the CDMO corporate entity within this year to seize the opportunity to secure demands from Chinese companies," Celltrion added. "Celltrion will secure a new manufacturing plant, as Celltrion's 100% owned subsidiary, in South Korea or overseas to expand production capacity." Additionally, as Trump's second administration's policy priority is the 'America First' agenda, Celltrion anticipates US dollar strength will likely result in trade disputes and interest rate rises. During the process, Celltrion anticipates its products will remain unaffected by tariff increases, as tariffs on drugs are exempt under the WTO's Pharma Agreement. "Upon Trump's second administration launches, we expect the company will have an opportunity to focus mainly on business aspects, marketing expansion and sales growth, compared to other type of business," Celltrion said. "Celltrion will focus on changes to the U.S. biopharmaceutical industry and generate outcomes by maximizing business opportunity," Celltrion emphasized.
- Company
- ‘Access to bispecific antibody Columvi should be improved’
- by Son, Hyung Min Nov 14, 2024 05:51am
- Dr. Chris Fox, Professor of Haematology at the University of Nottingham, U.K. “Diffuse large B-cell lymphoma (DLBCL) is a disease in which one in four patients experience relapse even after treatment. The bispecific antibody Columvi has demonstrated efficacy in relapsed patients at up to 18 months of follow-up. The clinical performance of Columvi is not just an incremental improvement over existing therapies, but a paradigm shift in the DLBCL treatment environment.” At a recent meeting with Dailypharm, Dr. Chris Fox, Professor of Haematology at the University of Nottingham, U.K., recently described so about Columbo, a bispecific antibody approved for diffuse large B-cell lymphoma in Korea. DLBCL is a disease in which the body's protective “B cells” grow or multiply uncontrollably and is the most common form of non-Hodgkin's lymphoma that accounts for about 40% of all non-Hodgkin's lymphomas. The disease is characterized by aggressive, rapidly progressive staging. The number of DLBCL patients in Korea was 14,183 as of last year, a 36% increase from the 10,428 in 2018. Up to 15% of DLBCL patients fail first-line standard therapy, and 25% of patients experience relapse within 18 months despite achieving a complete response (CR). Patients with relapsed or refractory DLBCL show a characteristically rapidly worsening prognosis as the number of treatment cycles increases. Columvi, the first bispecific antibody targeting CD20XCD3 enters the market...offers the advantage of a fixed dosing period The good news is that a variety of new drugs have emerged for this disease. Roche's Polivy, a representative DLBCL drug, is said to be effective in about two-thirds of patients when used as a first-line treatment. However, this means that about one-third of patients who do not respond to first-line treatment remain in need of further options. Bispecific antibodies and chimeric antigen receptor T-cell (CAR-T) therapy, such as Columvi, are used in such cases of relapse. Columvi, the first bispecific antibody to target CD20xCD3 in DLBCL, was launched without reimbursement in Korea in May and is now on the formulary of more than 10 general hospitals. The drug has a 2:1 structure that binds to two CD20 regions on the surface of malignant B cells and one CD3 region on immune T cells, resulting in a stronger binding. Bispecific antibodies have two targets, each targeting a different cell: one that draws immune T cells closer to malignant B cells and the other that activates the T cells to kill the malignant B cells. Based on this mechanism of action, bispecific antibodies have been shown to be effective in patients who are resistant to conventional antibody therapies or chemotherapy. “Bispecific antibodies and CAR-T therapies have been explored as treatment options for DLBCL, but without head-to-head trials, it is difficult to say which is better. The choice of treatment should be based on the individual patient's state of disease progression. However, one of the side effects of CAR-T in elderly patients, immune effector cell-associated neurotoxicity syndrome (ICANS), is considered when selecting a treatment,” said Dr. Fox. He added, “Columvi has a fixed dosing period. It is designed to be administered for up to 12 cycles (8.3 months), so there is a clear end date for the treatment. It also has the advantage of being an off-the-shelf treatment that can be administered to patients immediately.” Columvi achieves 39% CR rate - still effective after 18 months...“justifies the need for its reimbursement” Columvi demonstrated efficacy in the multicenter, open-label Phase I/II NP30179 trial in patients with relapsed or refractory DLBCL after two or more prior systemic therapies. Trial results showed that Columvi achieved a complete response (CR) of 40% and an overall response rate (ORR) of 52%. Among patients who achieved CR, the median duration of response was 26.9 months, with 67% of patients maintaining CR at 18 months. The study also included about one-third of patients who had received prior CAR-T therapy. “Columvi demonstrated a 40% CR rate in the trial, even in patients who are difficult to treat,” said Dr. Fox. This data alone confirms the efficacy of Columvi, as such data cannot be expected with existing standard treatment options, and Columvi is showing similar results in the real world to the clinical trial,” said Dr. Fox. “In DLBCL, relapse typically occurs within 12 to 18 months, and staging progresses rapidly in relapsed patients. We already have data on Columvi’s use in these patients up to 18 months of follow-up. So we can be confident about Columvi’s efficacy data and maintenance of its effect.” However, Columvi’s reimbursement was rejected in July by the Cancer Disease Review Committee, the first gateway to reimbursement in Korea, due to the lack of long-term data. Roche Korea is aiming to reapply for Columvi’s CDDC review later this year. “Patient access to Columvi has been secured in the UK with reimbursement approval,” said Dr. Fox. “This is because the health authorities have recognized Columvi as an effective treatment in DLBCL.” “Columvi is not just an improvement over existing therapies, but a paradigm-shifting treatment for DLBCL. I want to emphasize that this is a treatment that could have an impact on prolonging the survival of patients with relapsed or refractory DLBCL.”
- InterView
- 'Early detection of RA can help prevent severe symptoms'
- by Whang, byung-woo Nov 14, 2024 05:51am
- "Rheumatoid arthritis not only induces permanent joint deformities and damages but also has a detrimental effect on quality of life due to many general symptoms. As effective disease management becomes possible following the recent introduction of various treatment options, early diagnosis and patient-customized treatment approach are crucial." New treatment options for rheumatoid arthritis have improved unmet needs in clinical practices and increased disease awareness. However, despite the rising diagnosis rate, some patients receive a diagnosis after the disease progresses to severe symptoms. Yunjung Choi, Professor in the Division of Rheumatology at Jeonbuk National University Hospital, has emphasized the importance of early diagnosis of rheumatoid arthritis, explaining the disease characteristics and the latest treatment advances. Yunjung Choi, Professor in the Division of Rheumatology at Jeonbuk National University HospitalRheumatoid arthritis is the most common autoimmune disease where abnormally activated immune cells invade joints, causing inflammation and pain. "Rheumatoid arthritis is mainly caused by inflammation in the thin tissue lining of joints. The disease symmetrically affects small joints in the hand and foot, damaging bones and cartilage surrounding the tissue lining of joints. It leads to joint deformities and loss of joint function." Choi added, "JAK inhibitors that can be orally administered and have almost similar effects now enable patients to manage arthritis effectively." The treatment options for rheumatoid arthritis broadened following the introduction of conventional disease-modifying antirheumatic drugs (cDMARDs), biological agents, and Janus Kinase (JAK) inhibitors. "Patients who have not reached treatment goals after being treated with cDMARDs in primary healthcare centers are often transferred to secondary healthcare centers or university hospitals," Choi said. "Many of them are moderate to higher patients who have poor prognosis factors, and they consider either biological agents or JAK inhibitors." "Customizing treatment to individual patient is necessary. For instance, adapting to patient conditions to prevent and manage side effects, ensure administration convenience, and evaluate drug compliance," Choi emphasized. The current clinical practices use cDMARDS, biological agents, and JAK inhibitors based on the 2021 American College of Rheumatology Guideline and the 2022 European Alliance of Associations for Rheumatology classification recommendations. With JAK inhibitors recently added to the reimbursement list, patients now have treatment options that offer the convenience of oral administration, less burden than injectables, and high efficacy comparable to biological agents. Choi said such a change has contributed to increased patient drug compliance and provided effective treatment options to medical practitioners. Regarding the benefits of JAK inhibitors, Choi said, "At first, there were concerns about JAK inhibitors for cardiovascular system-associated side effects, but follow-up research outcomes have shown that such risks are gradually alleviating." Choi added, "We hope more data in South Korea becomes available and anticipate safer drug use considering ages and existing health conditions." "There is a need for improvements in the rheumatoid arthritis system with blind spot" Furthermore, there is a need to improve a system regarding drug switching for rheumatoid arthritis treatment. For instance, switching to another JAK inhibitor is difficult when a patient does not respond to a JAK inhibitor. Some people have demanded systematic improvements. Positive changes are expected regarding this issue. The Health Insurance Review and Assessment Service (HIRA) has suggested a criterion for drug switching needs, establishing 'An assessment criterion for evaluating drug switching effects for rheumatoid arthritis.' In addition, Choi emphasizes the need to expand support for patients with serotype-negative rheumatoid arthritis. "About 80% of patients with rheumatoid arthritis are diagnosed with antibody positivity. But, the rest of the 20% are found to be antibody-negative, posing difficulty in receiving benefits," Choi said. "These patients require treatments their whole lives, experiencing joint damage and functional deficits. Because they are excluded from benefits, improvements to the policy may be necessary." Additionally, Choi pointed out that patients who use biological agents are recommended for immunization to prevent shingles, but many experience considerable cost burdens. "Shingles immunization is crucial for patient safety, but its high cost poses an additional burden to patients. Systematic support is required to lower the economical hurdle," Choi said. Lastly, Choi reiterates the importance of early diagnosis to seize the 'golden time' for treating rheumatoid arthritis. "Many patients endure symptoms thinking that they feel pain from using their hands frequently, but end up visiting hospitals once the disease has worsened. When an individual feels one's hand stiff and hard to grasp, and feels extensive pain in the body, one should not disregard it simply as fatigue," Choi advises. When morning stiffness lasts over 30 minutes on more than two occasions within two weeks, it may indicate early rheumatoid arthritis. Individuals must consult rheumatology specialists for an accurate diagnosis and a suitable treatment plan. "An early intervention makes a significant difference in preventing joint damages and preserving quality of life," Choi said. "Patients need to recognize disease early and proactively seek treatments."
- Company
- Global CDMOs compete to expand ADC capacities
- by Kim, Jin-Gu Nov 14, 2024 05:51am
- Global competition is heating up in the contract development manufacturing organization (CDMO) market for antibody-drug conjugates (ADCs). Major players include Switzerland's Lonza and Samsung Biologics, the world's top two CDMOs, which are competitively expanding their manufacturing facilities. Lonza recently announced the expansion of a 1,200-liter ADC manufacturing facility, while Samsung Biologics announced the start-up of a 500-liter ADC manufacturing facility within the year. According to KoreaBIO, Lonza announced on Dec. 13 (local time) that it plans to add 2 manufacturing facilities in Visp, Switzerland, to expand its 'bioconjugation' service. An additional 1,200-liter manufacturing facility will be built to produce commercial bioconjugates, including ADCs, in high volumes. At the same time, the company will expand the infrastructure of the existing facility. Construction is expected to be completed and the facility fully operational by 2028. The new manufacturing facility will provide comprehensive end-to-end lifecycle support. This includes drug manufacturing for early-stage clinical development, large-scale manufacturing for commercial supply, and finished product filling services. Lonza has been in the bioconjugate CDMO business since 2006. To date, it has produced more than 1,-00 cGMP batches for more than 70 programs. Christian Morello, Vice President, Head of Bioconjugates, Lonza, said, “We continue to see strong growth in the bioconjugates space as ADCs and other bioconjugated drugs increasingly progress towards commercialization. This investment in our multipurpose commercial bioconjugation capacity addresses the growing market demand, enables us to support the growth of our customers, and offers a flexible and integrated service for manufacturing bioconjugates.” The global CDMO market, including Lonza, has recently been intensely competing to expand capacities around ADC drugs. Samsung Biologics is building a dedicated 500-liter ADC manufacturing facility at its Songdo Biocampus in Incheon, South Korea. The company plans to finalize the construction this year and begin full-scale operation after receiving GMP approval. Lotte Biologics is expanding its ADC manufacturing facility at its Syracuse, USA plant. This is an investment of USD 80 million (approximately KRW 100 billion). The ADC manufacturing facility is currently being expanded and is targeting GMP approval in the first quarter of next year. The company is also in the process of building a related plant in Songdo, Incheon. In addition, Celltrion plans to establish a separate CDMO subsidiary while pursuing ADC drug development. Kyongbo Pharmaceutical is investing KRW 85.5 billion to build an ADC plant. The reason why domestic and foreign CDMOs are rushing to expand production capacity for ADC drugs is due to their marketability and high barriers to entry. ADC is a type of antibody conjugated with a cytotoxic drug (payload) as a linker. They have a high structural complexity compared to conventional antibody drugs, which makes the development and manufacturing process difficult, but they have emerged as the next generation of biopharmaceuticals due to their relatively high therapeutic efficacy and low side effects. Following the success of Daiichi Sankyo's breast cancer drug Enhertu (trastuzumab deruxtecan), research on ADC drugs has increased explosively worldwide. However, facilities for the development and mass manufacture of ADC drugs have not been able to keep pace. This is why an imbalance between ADC-related research and manufacturing is expected in the field. Unlike conventional antibody drug CDMOs, ADC-specific manufacturing facilities require more particular technologies. Unlike antibody drug production facilities, ADC production facilities must incorporate additional design principles because they handle cytotoxic drugs (payloads) and organic solvents. Additional design details include negative pressure design, differential pressure between cleanrooms, and airlocks to prevent the spread of cytotoxic drugs and protect operators.
- Product
- MOHW cautions non-face-to-face Wegovy prescriptions
- by Kang Hye-Kyung Nov 13, 2024 05:55am
- The government has asked medical institutions for cooperation in making indiscriminate Wegovy prescriptions. The Ministry of Health and Welfare said on the 11th through the medical community, “Regarding Wegovy, which was recently released as a treatment for obesity, medical institutions are issuing prescriptions without sufficiently examining the patient's condition, raising concerns of its abuse and misuse.” The ministry emphasized, ”Wegovy is administered as an aid for weight management for obese patients, and side effects may occur if used regardless of the patient's medical condition.” The MOHW also asked institutions to comply with the MFDS’s approved indication, which specifies Wegovy’s use as an adjunct for managing weight in people with ▲a BMI of 30 kg/m² or greater (obesity) or ▲a BMI of at least 27 kg/m² but less than 30 kg/m² who have weight-related health problems (such as diabetes, high blood pressure, abnormal levels of fats in the blood, breathing problems during sleep called ‘obstructive sleep apnoea’ or a history of heart attack, stroke or blood vessel problems), or to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction or stroke) in people with confirmed cardiovascular disease who are ▲either obese or overweight with a BMI of at least 27 kg/m². They also ordered that patients should be properly screened to determine if they are eligible and that they should be informed of possible side effects, including gallbladder disease, intestinal obstruction, aspiration pneumonia, pancreatitis, acute heart injury, hypoglycemia, various gastrointestinal, metabolic, neurological disorders, and suicidal thoughts. In addition, the ministry asked doctors to be careful not to mislead patients into believing that Wegoby can easily be prescribed for weight loss, and to be vigilant in preventing the misuse of such drugs during virtual visits.
- Opinion
- [Reporter's View] voluntary resignation with compensation
- by Lee, Seok-Jun Nov 13, 2024 05:54am
- As the year-end is nearing, several pharmaceutical companies are considering restructuring. Rumor has it that these companies may have plans for reducing OTC businesses and laying off staff who are age 55 or older. It remains uncertain whether it is a rumor or an actual plan, but restructuring could be possible. Over five pharmaceutical companies that were mentioned. There is a solid reason companies have chosen restructuring. It is for business efficiency. Restructuring could be an enormous benefit if laying off results in efficiency within the company. It is an approach of 'selection and focus,' losing a few if taking all is not an option. Voluntary resignation is frequently used as a method of job cuts. It is implemented to reduce the number of employees at once. It is the same as layoffs in business. However, companies utilize the voluntary resignation program instead of layoffs because layoff requirements are selective according to the Labor Standards Act and may result in conflicts and management. Korean pharmaceutical companies employ a similar method. Voluntary resignation is less frequent than that of the multinational companies, but the Korean companies have used it more often recently. At the end of last year, Korean mega-pharmaceutical companies, Ildong Pharmaceutical and GC Biopharma, conducted voluntary resignations. Likewise, Korean pharmaceutical companies are favor voluntary resignation when reducing the number of employees. Then, what is the next important step? We must consider compensation for those who are subjected to restructuring. Pharmaceutical companies' goal for restructuring is to reduce the number of employees. However, it would be better to achieve such a goal by offering a good compensation package. If restructuring is inevitable, a win-win structure must be set. Although companies may have to spend a large sum of money at once, they may have to sacrifice considering the cost-effective outcomes in a few years following restructuring. Yet, a compensation criterion has not been established for voluntary resignation. Compensation criterion vastly differs by company. Direct comparison may be difficult, but the criterion in Korean companies is different from the (consecutive years of service*2)+ N months in multinational companies. Few companies urge voluntary resignation without compensation. Companies will continue to undergo restructuring. Then, it will be necessary for Korean companies to establish a compensation criterion for voluntary resignations. Precedence will serve as a standard for those who follow. If leading restructuring companies set low compensation, latecomers will also set low standards. The situation in small and medium-sized companies will be much worse, causeing a vicious cycle. Now, an agreement between Korean companies for voluntary resignation compensation may be necessary. Better compensation will lessen the backlash from restructuring.
- Company
- Imfinzi combo drug Imjudo can be prescribed at hospitals
- by Eo, Yun-Ho Nov 13, 2024 05:54am
- Immuno-oncology drug Imfinzi's combination partner Imjudo may now be prescribed in general hospitals in Korea. According to industry sources, AstraZeneca Korea's CTLA-4 inhibitor Imjudo (tremelimumab) has passed the drug committees (DCs) of tertiary hospitals in Korea including Seoul National University Hospital and Seoul Asan Medical Center. For now, however, Imjudo is a non-reimbursed drug. AstraZeneca submitted an application for the reimbursement of the PD-L1 inhibitor Imfinzi (durvalumab) and Imjudo combination for liver cancer in June and is currently awaiting a review by the Health and Insurance Review and Assessment Service’s Cancer Disease Review Committee. Imjudo was approved by the Ministry of Food and Drug Safety in combination with Imfinzi in June last year. The first target indication for the combination is liver cancer and can be prescribed as a first-line treatment for adult patients with advanced or unresectable hepatocellular carcinoma (HCC). The specific regimen is the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen, which consists of a single dose of Impinj 1,500 mg plus 300 mg of Imfinzi, followed by an additional dose of Impinj at regular intervals every 4 weeks. At the recent European Society for Medical Oncology (ESMO) Congress 2024, the 5-year overall survival data from the Phase III HIMALAYA trial that demonstrated the efficacy of the Imfinzi and Imjudo combination in hepatocellular carcinoma was presented. In the HIMALAYA trial, patients with inoperable HCC were treated with STRIDE (single dose of Imjudo followed by Imfinzi maintenance therapy), Imfinzi monotherapy, and sorafenib monotherapy. When comparing the results of the Imfinzi and Imjudo combination with sorafenib combination therapy in patients with unresectable HCC, patients who received the STRIDE regimen had a 5-year overall survival (OS) rate of 19.6%, compared with the 9.4% for patients who received sorafenib. The median overall survival was 16.43 months and 13.77 months, respectively, showing a 24% lower risk of death in the Imfinzi-Imjudo combination arm. “ The Imfinzi-Imjudo combination therapy has significant advantages in that it has a much lower risk of bleeding than conventional therapies and does not worsen liver function," said Hong Jae Chon, Professor of Hemato-Oncology at CHA Bundang Medical Center. “In particular, the combination shows potential for longer survival than existing therapies."
- Company
- Treatment-refractory Dravet syndrome calls for new options
- by Whang, byung-woo Nov 13, 2024 05:54am
- Despite increased treatment options for the ultra-rare Dravet syndrome, there are still gaps in care that require attention. Even with the introduction of medical cannabis, cannabidiol, there are patients who do not respond to the drug, which is why improving access to new options should be considered. Dravet syndrome is a rare neurological disorder that begins with fever and convulsions within the first year of life, persists into adulthood, and leaves nearly all young patients moderately to severely disabled after each attack. Although it is known to be a rare disease with an estimated prevalence of 1 to 2 per 10,000 people worldwide, there is no officially investigated prevalence in Korea and was designated as an ultra-rare disease in 2022. Dravet syndrome is characterized by the onset of the first seizure, which is similar to a febrile convulsion that usually occurs with fever at 6 months. The biggest risk factor is “Sudden Unexpected Death in Epilepsy” (SUDEP). While the rate of sudden death in intractable epilepsy is 20-25%, in Dravet syndrome, up to 59% of all deaths are associated with SUDEP. The goal of treatment for Dravet syndrome is to control seizure frequency and non-seizure symptoms to reduce the patient's risk of sudden death and improve quality of life. Initial treatment includes anti-seizure medications and add-on treatments such as the anti-seizure medications stiripentol and cannabidiol are used to treat the “drug refractory” nature of Dravet syndrome. Cannabidiol is a medical cannabis preparation that was previously supplied without reimbursement through the Korea Orphan & Essential Drug Center for urgent use but then has been reimbursed since April 2021. Hoon-Chul Kang, professor of pediatric neurology at Severance Hospital, emphasized that the government's approval of medical cannabis has contributed to improving the treatment environment for Dravet syndrome. Kang said, “The government's decision was based on the desperate voices of parents and caregivers of children with Dravet syndrome, as well as objective data reported in the literature,” he explains. Limitations remain for drug-refractory Dravet syndrome...a fundamental solution is needed However, stiripentol and cannabidiol are only available through the Korea Orphan & Essential Drug Center, and the treatment process from applying for the drugs to meeting the criteria for reimbursement coverage is rather complicated. Hoon-Chul Kang, professor of pediatric neurology at Severance Hospital Hoon-Chul Kang, professor of pediatric neurology at Severance HospitalIn particular, there are still many patients with Dravet syndrome who are refractory to existing medications, leaving a blind spot in terms of seizure management. Unlike Korea, where treatment options are limited, options are increasing overseas with the emergence of new options. In the long run, experts agree that Korea also needs a fundamental treatment for seizures that reduces the quality of life for people with Dravet syndrome and their caregivers. If a new treatment option can significantly improve seizure control while also managing additional comorbidities and disabilities, it would substantially improve the treatment landscape. In addition, despite the limitations of being an ultra-rare disease, there are expectations that Dravet syndrome will benefit from the government's 'fast-track program for serious and rare diseases to reduce the burden of medical expenses’ plan. The industry predicts that the government's interest in pediatric rare and intractable diseases will continue for the time being, given the revised pediatric drug pharmacoeconomic evaluation exemption system last year and the selection of drugs for the first pilot project for the approval-evaluation-negotiation linkage system. A professor of pediatrics at a tertiary hospital said, "The government needs to make another timely decision to improve the treatment environment for Dravet syndrome, an extremely rare disease that is even more neglected than others."
