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- Somavert can be prescribed at general hospitals
- by Eo, Yun-Ho Nov 16, 2021 05:52am
- According to related industries, Pfizer Korea's Somavert (Pegvisomant) has currently passed the Drug Committee (DC) of medical institutions such as Seoul National University Hospital and Sinchon Severance Hospital, and is also undergoing procedures at medical institutions such as Seoul National University Bundang Hospital, Wonju Severance Hospital, and Samsung Medical Center. In the case of terminal hypertrophy, Sinchon Severance Hospital is taking care of the largest number of patients, so it is expected to lead to prescription fast. Somavert has been listed on the insurance benefit list since September. Somavert demonstrated its validity through a 12-week randomized, double-blind study of 12 patients with terminal hypertrophy. The study found that the median serum IGF-I concentration at 12 weeks of study compared to the baseline was 4.0±16.8%, 26.7±27.9%, 50.1±26.7%, and 62.5±21.3%, respectively, in the placebo group, Pegvisomant 10 mg group, Pegvisomant 15 mg group, and Pegvisomant 20 mg group. The proportion of patients whose serum IFG-I concentration returned to normal compared to baseline was also found to be significantly higher than that of placebo, Pegvisomant 10 mg/day administration group, Pegvisomant 15 mg/day administration group, and Pegvisomant 20 mg/day administration group, respectively, indicating that Pegvisomant was significantly higher than placebo. Meanwhile, Somavert was approved in Korea in September last year for the treatment of adult terminal hypertrophy patients who do not respond appropriately to surgery and radiation therapy, or whose IGF-I (Insulin-like growth factor I) concentration is not normalized by somatostatin analog therapy, and was designated as a rare drug in 2018.
- Company
- Sales of Arcoxia (Etoricoxib) are sluggish
- by Kim, Jin-Gu Nov 16, 2021 05:52am
- Generics for Arcoxia, an anti-inflammatory pain reliever based on COX-2 inhibitors (Etoricoxib) have been released, but sales in the market are sluggish. This is because there is still a high preference for original drugs at the medical site, and even the original drugs are pushed back by Celebrex, a leading item in the same family market. According to UBIST, a pharmaceutical market research firm on the 11th, the total prescription amount for generics for Arcoxia from June to September is around 31 million won. During this period, the original prescription amount is around 730 million won. Generic prescriptions account for only 4% of the original. Generics challenged Arcoxia's patent in September 2019. In April last year, it won the passive trial to confirm the scope of rights. It succeeded in avoiding patents that were scheduled to expire in 2023. Theragen Etex, Guju, Hana, Hutechs, Union Korea, Aju, Daewoo, Boryung, Arlico, and Reyon received generic for exclusivity from April this year to January next year. Generics have been released in earnest since June this year. Aju, Arlico, Hutechs, Hana, Theragen, and Etex are confirmed to have released generics one after another. However, for four months, their total prescription amount is only 31 million won. Hana's sales are the highest at 19 million won, and sales of the other generics are less than 10 million won. This is because the original preference is still high at the prescription site. As of last year, outpatient's prescription for Celebrex amounted to 44.7 billion won. It is more than 12 times Arcoxia's sales of 3.5 billion won.42 billion won and 2.7 billion won worth of prescriptions were prescribed by the third quarter, respectively, widening the gap by 15 times. Since 2010, more than 200 generics for Celebrex have been competing. Generics for Arcoxia have little time to compete. The generic for exclusivity period will end in January next year, but no company has started developing generics for Arcoxia yet.
- Company
- The price reduction of PE waiver drugs
- by Eo, Yun-Ho Nov 15, 2021 06:29pm
- KRPIA expressed serious concern in a comment on the 10th that the HIRA was confirmed to evaluate the cost effectiveness at 80% of the lowest A7 adjustment price when asked about the cost-effectiveness criteria of Kim Mi-ae, a member of the National Assembly. KRPIA said, "In the course of discussions with the HIRA, we have repeatedly expressed opinions that uncertainties arising from the application of the risk-sharing system in A7 countries should be flexibly evaluated according to the characteristics of each drug." In addition, it pointed out, "If the figure of 80% for which the basis for calculation is not clear is applied collectively, access to drugs subject to PE exemption, which are limited to patients with rare and severe diseases, may be severely reduced." The PE waiver drug system is mandatory to limit the total amount of annual use in response to uncertainties in A7 national indicators, and if overseas prices are further lowered during the follow-up period, tight financial management is already taking place. KRPIA said, "If we have to further cut the drug price by 20% to 80% of the lowest price in A7 countries, PE waiver drugs will actually be privately cultured. In addition, considering the purpose of the system to guarantee drug prices for drugs that need to be registered, if the HIRA sets the lowest price as an internal operating standard and applies it collectively to all drugs, there is a possibility of abuse of discretion in violation of the principle of trust protection." In addition, it pointed out that it could violate the national treatment regulations of the Korea-US FTA and the Korea-EU FTA, stressing that if the administration is operated based on an undisclosed internal operation standard and the evaluation criteria of PE waiver drugs are changed, it can be seen as a de facto discrimination measure. KRPIA said that the HIRA-industry meeting on June 17 and the MOHW's public-private consultative body on July 28 consistently argued that the application of specific figures is inappropriate and should be evaluated according to the characteristics of each drug.
- Company
- Will sales of flu treatments be recovered?
- by Chon, Seung-Hyun Nov 15, 2021 05:56pm
- According to UBIST, a drug research institute, on the 14th, the amount of outpatient prescriptions for flu treatments in the third quarter was only 7.97 million won. It fell 31.1% year-on-year. It decreased by 75.2% from the same period two years ago. The flu treatment market has been prescribing less than 100 million won for six consecutive quarters since the second quarter of last year. The market size has been insignificant since it plunged 99.8% to around 10 million won in the second quarter after hitting 8.4 billion won in the first quarter of last year. The prescription amount in the fourth quarter of last year and the first quarter of this year, which are flu epidemic seasons, was only 20 million won and 10 million won, respectively. Quarterly outpatient Rx amount for flu tx (unit: 1 million won, data: UBIST) Sales in the Oseltamivir market, the most prescribed flu treatment, have decreased significantly. Oseltamivir is the active ingredient of Tamiflu. In the third quarter, the prescription for Oseltamivir was only 7.97 million won. It fell 31.1% year-on-year and 74.3% year-on-year. Oseltamivir prescription performance soon becomes sales in the entire flu treatment market. Since the third quarter of last year, the overall prescription performance of Oseltamivir has occurred only in one item of Tamiflu. Since the third quarter of last year, there seems to be no flu treatment except for Tamiflu. This is a change in the prescription market due to the prolonged COVID-19. This is because after the spread of COVID-19, the incidence of infectious diseases has decreased significantly due to strengthening personal hygiene management such as washing hands and wearing masks, and only Tamiflu has been prescribed when patients occasionally occur. According to The KDCA, the number of suspected flu patients per 1,000 outpatients has never exceeded the epidemic standard of 5.8 this year. Status of influenza suspected cases per 1,000 outpatients (unit: name, data: the KDCA) In the ninth week of last year, the number of suspected flu patients per 1,000 outpatients recorded 6.3 and remained at the level of two to three. There have been few flu patients for about a year and eight months since early March last year. Even this month, when the winter season began in earnest, the number of suspected flu patients per 1,000 outpatients was only 3.3. In this situation, the possibility of the spread of infectious diseases such as the flu is being raised as face-to-face contact expands due to the lifting of the time limit for multi-use facilities due to the daily recovery of COVID-19. However, it is unlikely to lead to a sudden spread of infectious diseases as hygiene management such as wearing a mask is still strictly observed. An industry official said, "Since there have been few flu patients this year, production and supply of flu treatments have been virtually suspended," adding, "We will consider expanding the production and supply of treatments while looking at the increase in the number of patients."
- Company
- K-COVID-19 vaccine developers will ‘power through till end'
- by Kim, Jin-Gu Nov 15, 2021 05:56am
- Domestic vaccine developers have been accelerating the last phases of their clinical trials. SK Bioscience and Genexine have started Phase III trials in Korea and abroad, and Cellid has submitted its Phase IIb/III clinical trial plan. Domestic developers have come up with new strategies to continue the development of their vaccines with the value of latecomer vaccines lowering due to the domestic vaccination rate reaching nearly 80% in Korea and the introduction of oral COVID-19 treatments imminent. ◆Cellid applied for Phase 2b/3 trial… starts development of a vaccine against variants If the clinical trial protocol is approved, the Phase IIb clinical trial will be conducted on 125 participants, and Phase III on 4,100 participants. The Phase III trial will compare AdCLD-CoV19-1 with AstraZeneca’s COVID-19 vaccine. Cellid has started a new clinical trial for its existing candidate ‘AdCLD-CoV19' after revising its virus vector. The production yield rate change has improved with the revision of the virus vector. Upon completing the phase 2a trial, Cellid said in June that it would newly develop AdCLD-CoV19-1, a revised version of the virus vector vaccine, for mass production. In addition, the company obtained the regulatory nod for a phase 1 study of AdCLD-CoV19. Apart from this, Cellid is also concurrently developing a new vaccine candidate that responds to COVID-19 variants including the Delta variant. Animal testing is currently underway for the new vaccine candidate. Cellid expects it would be able to enter Phase I clinical trials for its variant vaccines next year at the earliest. The company’s experience with its Phase IIb/III trial for AdCLD-CoV19-1 is expected help accelerate its development. Cellid’s two-track development strategy is not unrelated to the COVID-19 vaccine and treatment development situation in Korea and abroad. With the market value of latecomer vaccines decreasing, the companies have explained that the changes in their development strategies were inevitable. As of midnight on the 12th, the domestic COVID-19 vaccination rate in Korea reached 77.6 % (full vaccination rate). Therefore, the possibility of not many candidates being left for vaccination even if the company completes its vaccine development by the first half of next year as planned. Remains. In addition, the value of the latecomer vaccine has been rated even lower with the imminent introduction of oral coronavirus treatments. ◆SK Bioscience signs agreement to supply its vaccine to developing countries… Genexine to develop a vaccine as booster shot SK Bioscience and Genexine, which have started their Phase III trials ahead of Cellid, have also been facing the same dilemma. SK Bioscience plans to finish development and expand its supply to developing countries around the world by early next year. SK Bioscience signed a supply agreement with CEPI (The Coalition for Epidemic Preparedness Innovations) for the provision of its vaccines. After GBP510 is developed and is selected for the “Wave 2” (next-generation COVID-19 vaccine) project, the vaccine will be supplied globally, in Africa, South America, and Southeast Asia through the COVAX Facility. The global vaccination rate has reached around 51.3%. In developing countries, the rate is around 10% or less. Therefore, unlike in the domestic market, a sufficient supply market remains for the vaccines globally. SK Bioscience initiated its Phase III trial in August. The company expects the trial to be finalized and be approved by 1H next year. In the case of Genexine, the company changed its vaccine development strategy to developing booster shots. In August, the company applied to change its clinical trial plan for the global Phase II/III trial it has been conducting for ‘GX-19N’ in Indonesia in August. The new strategy is to develop a booster vaccine with its vaccine candidate. The clinical trial will confirm the protective efficacy of GX-19N in 1,000 participants who had been vaccinated with Sinovac or Sinopham’s inactivated vaccines 3 months earlier. Genexine plans to expand the clinical trials in Indonesia to Argentina and other countries in 14,000 patients. However, the analysts are that the decision may have been influenced by the fact that the drug, if developed, will not have much marketability, like other vaccine developers.
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- Hanmi Pharmaceutical's first technology export in a year
- by Chon, Seung-Hyun Nov 12, 2021 05:56am
- Hanmi Pharmaceutical is speeding up its efforts to secure profits from technology fees, which had slowed down for a while. It has secured a down payment of 10 billion won by exporting new drug technology in the past year, and expectations are high for subsequent new drug development. According to an industry on the 11th, Hanmi Pharmaceutical exported FLT3 inhibitor "HM43239," which is being developed as an innovative drug for AML treatment, to Aptose Biosciences on the 4th. Under the contract, Hanmi Pharmaceutical will receive a $12.5 million down payment (about 15 billion won) from Aptose Biosciences in cash and $7.5 million in Aptose Biosciences shares. After that, it will receive up to $47.5 million (about 485 billion won) in clinical, development, permission, and commercialization milestones for various indications. You will also receive a step-by-step royalty for sales. Hanmi Pharmaceutical completed the export of new drug technology in a year and three months. Hanmi Pharmaceutical exported a non-alcoholic steatohepatitis treatment to MSD in August last year. The GLP-1-based double agent whose rights were returned from Janssen was transferred back to MSD after a year. It is a double-acting treatment that simultaneously activates GLP-1, which helps secrete insulin and suppress appetite, and glucagon, which increases energy metabolism, and Hanmi Pharmaceutical's original technology for lapscovery, which increases drug efficacy duration, is applied. Hanmi Pharmaceutical's new technology export contract is also expected to expand technology fee profits. Hanmi Pharm is expected to temporarily recognize the down payment of $5 million (about 6 billion won) received in cash from Aptose Biosciences as technology fee revenue. Hanmi Pharmaceutical has established its technology fee revenue in earnest since 2015 when it began to produce technology export results in earnest. However, in recent years, when technology exports have become less successful, technology fee profits have decreased significantly. Until the third quarter of this year, Hanmi Pharmaceutical's technology fee revenue was only 200 million won. No technology fee revenue was generated in the first and second quarters, and 200 million won flowed in in the third quarter. Hanmi Pharmaceutical earned a total of 512.5 billion won in technology fees from down payments received from Lily, Beringer, Sanofi, and Janssen in 2015 and secured more than 10 billion won in technology fees every year. Hanmi Pharmaceutical posted 27.7 billion won in technology fees in 2016, which is the result of returning some of them due to the revision of the contract with Sanofi. Initially, Hanmi Pharmaceutical received a down payment of 400 million euros in 2015 when it signed three technology transfer contracts with Sanofi. At this time, Hanmi Pharmaceutical reflected only KRW 255.6 billion in its accounting books and chose a method of recognizing the rest in installments for 36 months. At the end of 2016, Hanmi Pharmaceutical returned 로를196 million through contract modification, including the return of the rights of some tasks (continuous insulin). Hanmi Pharmaceutical remitted about 160 million euros by revising the contract without recognizing about 160 billion won in down payment received from Sanofi as revenue (255.6 billion won in 2015 and 63.9 billion won in the first to third quarters of 2016). Hanmi Pharmaceutical earned 57.7 billion won in 2017, 44.6 billion won in 2018, and 20.4 billion won in 2019. During this period, the down payment received from Genentech was recognized in installments. Hanmi Pharmaceutical signed a technology transfer contract with Genentech in September 2016 for the RAF target anticancer drug "HM95573. If the down payment is $80 million and clinical development, permission, and commercialization are successful, the condition is to receive $830 million sequentially as a step-by-step milestone. Hanmi Pharm received a down payment of $80 million from Genentech on December 2, 2016. At that time, 93.8 billion won was deposited if 1,173 won was applied based on the won-dollar exchange rate. Hanmi Pharmaceutical recognized the down payment in installments for 30 months on its accounting books, and the period of recognition of the down payment in April 2019 ended. Last year, the company temporarily recognized $10 million in down payment secured through a technology export contract with MSD, generating 10 billion won in technology fee revenue. Hanmi Pharm has also secured additional milestones following the development of the anticancer drug "Auraxol" exported to Athensx. Hanmi Pharmaceutical can secure additional technology fees according to the development of technology export tasks. Belvarafenib, which transferred technology to Genentech, is currently conducting global clinical trials for commercialization by Genentech and Roche. "belvarafenib" is a pan-RAF inhibitor-based targeted anticancer drug. It acts as a mechanism to inhibit RAF, a type of mitogen-activated protein (MAP) kinase that mediates intracellular signaling. Genentech has proven excellent drug resistance and safety in combination with existing approved treatments and plans to expand global clinical trials for patients with NRAS melanoma. Roche added two cohorts of belvarafenib-related monologues and combination therapy to its ongoing large-scale clinical project, "TAPISTRY." "TAPISTRY" is a clinical trial aimed at providing customized treatments to metastatic solid cancer patients who cannot operate with certain mutations. According to a quarterly report submitted to the U.S. Securities and Exchange Commission by Hanmi Pharmaceutical's partner Spectrum Pharmaceuticals, Spectrum agreed to pay up to $358 million in milestones to Hanmi Pharmaceutical according to the commercialization performance of the anticancer drug Poziotinib. Spectrum plans to submit an application for FDA approval as early as this year. If "Rolontis," a treatment for neutropenia that has been applied for permission from the U.S. Food and Drug Administration (FDA), is approved, it will pay $10 million to Hanmi Pharmaceutical. Poziotinib is a pan-HER2 anticancer drug that Hanmi Pharmaceutical transferred to Spectrum in 2015. Rolontis, which was transferred to Spectrum in 2012, is a new biopharmaceutical applied with Hanmi Pharmaceutical's Labscovery platform technology that increases the duration of the drug's efficacy in the body.
- Company
- GX-17, aimed at treating COVID-19, resumes clinical trials
- by Kim, Jin-Gu Nov 12, 2021 05:54am
- Genexine's new anticancer drug candidate GX-I7, which had shown potential as a treatment for COVID-19, will launch a new clinical trial for anticancer drugs. On the 10th, the MFDS approved phase 2 clinical trials of Bevacizumab and Genexine GX-I7 in recurrent glioblastoma. Bevacizumab is the active ingredient of Roche's target anticancer drug Avastin. GX-I7 is a substance that Genexine is developing as a new anticancer drug. In 2017, the company launched phase 1b clinical trials for metastatic and recurrent solid cancer and began developing new anticancer drugs in earnest. Since then, he has initiated phase 1b combination therapy with cyclophosphamide in solid cancer in 2018, phase 1b/2 with Pembrolizumab (Keytruda) in recurrent and non-adaptive triple negative breast cancer, and phase 1/2 with Temozolomide (Temoram) in 2019. After the COVID-19 crisis began in earnest, the possibility as a treatment for COVID-19 was expected. In August 2020, it was approved for phase 1b clinical trials in Korea for mild COVID patients. In the United States, Genexine's U.S. affiliate NeoImuneTech launched phase 1 clinical trials for COVID-19 patients in November last year. However, in the case of COVID-19 clinical trials, it is prolonged than originally expected. The domestic clinical trial was to be conducted on 40 patients, but the recruitment of patients was still not completed after recruiting the first patient in March, seven months after clinical approval. US clinical trials of 30 people are also still recruiting patients. In this situation, Genexine is focusing again on clinical trials of GX-I7 anticancer drugs. In fact, it is confirmed that Genexine has recently been approved for clinical trials of anticancer drugs not only in Korea but also in the United States. Last month, NeoImuneTech launched phase 2 clinical trials for combination therapy with Atezolizumab (Tecentriq) of NT-I7 (US Development Name of GX-I7) in non-small cell lung cancer. Prior to this, in January this year, it was approved for phase 2 clinical trials with Opdivo for gastric and esophageal cancer patients. In August, phase 1b clinical trials were launched for patients with recurrent and refractory giant B-cell lymphoma. In addition to GX-I7, Genexine is developing GX-19N as a COVID-19 vaccine. Phase 1/2a clinical trials have been completed in Korea, and phase 3 global clinical trials are currently underway in Indonesia, Argentina, and Turkey. Genexine plans to release GX-19N in the first half of next year.
- Company
- Will BMS's 'Revlimid' be reimbursed as RVd therapy?
- by Eo, Yun-Ho Nov 11, 2021 06:01am
- Whether the multiple myeloma treatment ‘Revlimid’ will succeed in expanding reimbursement to its use in RVd therapy is gaining attention. According to industry sources, reimbursement of Revlimid (lenalidomide) for RVd therapy (Lenalidomide + bortezomib + dexamethasone) passed the Health Insurance Review and Assessment Services’ Cancer Disease Deliberation Committee review in September and is awaiting deliberation by the Pharmaceutical Benefits Appraisal Committee. The agenda is expected to be presented for PBAC deliberation in December. In Korea, the standard first-line therapy for multiple myeloma under reimbursement includes VMP (bortezomib+ melphalan+ prednisolone) and Rd (lenalidomie+dexamethasone) in patients who are not eligible for stem cell transplants, and VTd (bortezomib+thalidomide+dexamethasone) for patients eligible for stem cell transplants. However, the 5-year relative survival rate of multiple myeloma patients in Korea remains in the 40% range. RVD therapy is recommended as a priority in the first-line treatment of multiple myeloma in the US NCCN guidelines and EHA-ESMO guidelines. According to HIRA, among the 8,929 patients in Korea who were treated for multiple myeloma in 2020 (diagnosis code: C90, multiple myeloma, and malignant plasma cell neoplasms), 47% were over the age of 70 and were ineligible for transplant under the reimbursement standards. Elderly patients over the age of 70 have limited treatment options as they have difficulty receiving stem cell transplants, raising the demand for RVd reimbursement. Seok-Jin Kim, Professor of Hematology-Oncology at the Samsung Medical Center, said, “Treatment of multiple myeloma requires multiple considerations from the medical aspect as well as in the patient’s condition, treatment sequence, reimbursement conditions, etc. Both the patients and us HCPs will welcome a treatment option with a promising prognosis that can be used freely without reimbursement restrictions." He added, “I hope reimbursement for multiple myeloma treatments is extended to cover RVd therapy, maintenance therapy after autologous hematopoietic stem cell transplant, and R2 in follicular lymphoma to benefit more patients.” In a Phase III clinical trial, RVd therapy significantly extended PFS (progression-free survival) and OS (overall survival) compared to Rd therapy in patients with newly diagnosed multiple myeloma that are ineligible for stem cell transplant. In a network meta-analysis that assessed the relative efficacy of MM drugs used in newly diagnosed patients that are ineligible for stem cell transplant, RVd demonstrated significant extension in PFS and OS over Rd, and Rd over VMP.
- Company
- What do scholars refer to as effective tx for myeloma?
- by Nov 11, 2021 06:00am
- With the release of various new drugs over the past decade, treatment results for multiple myeloma have been gradually improving. This is because as options vary, opportunities for "customized treatment" to select drugs depending on patients expand. Professor Eom Hyun-seok (left) and Professor Kwee Yong (right) who are conducting video talks Medical staff's attention is focused on which patients should be used to maximize the effectiveness. In particular, third-drug therapy centered on second-generation proteasome inhibitors (PI) is a trend in patients with first recurrence. As KRd therapy (Carfilzomib+ Revlimid +Dexamethasone) centered on Kyprolis and IRd therapy (Ixazomib+Revlimid+Dexamethason) centered on Ninlaro compete, the process of identifying appropriate drug choices considering drug characteristics and patient conditions continues. Takeda held an academic conference between British and Korean medical staff on the treatment of recurrent and refractory multiple myeloma according to patient characteristics such as disease risk and cytogenetic high-risk groups. Eom Hyun-seok, director of the National Cancer Center Hospital (Professor of Hematology and Oncology), an authority in the field of blood cancer, and Kwee Yong, a professor at University College London, participated in the meeting. Professor Eom Hyun-seok: What are the guidelines for selecting IRd and KRd as secondary therapies for patients with recurrent and refractory multiple myeloma? Professor Kwee Yong: Proteasome inhibitor and Lenalidomide combination therapy are very good methods in secondary treatment. Most patients will reach a therapeutic response with this combination therapy. The issue is which one to choose between IRd and KRd. The risk of the disease is first identified, and then whether it recurred early or aggressive. If the disease is aggressive and recurs early, has extra-bone marrow lesions, has high M protein levels, and the disease progresses quickly, KRd should be selected. However, patients should be young and able to visit the hospital every week. It is a very intensive treatment. On the contrary, if the condition is not aggressive and recurrence is not carried out early, so the progressive survival period (PFS) is at least 18 to 24 months, IRd will be selected. It is a fairly comfortable treatment for patients in many aspects. The side effects of KRd's Kyprolis require more careful attention. In particular, they have a history of heart disease or kidney damage. Professor Eom Hyun-seok: If so, can high-risk groups be classified into KRd according to the patient's risk and IRd if it is a general risk? Professor Kwee Yong: There is no clear standard. This is because IRd responses are very good even in patients who are genetically at high risk. If we have to make a distinction, the aggression of the disease, the pace of disease progression, and the burden of the disease will be more consistent. Professor Eom Hyun-seok: How do you see the use of IRd in multiple myeloma with advanced extra-bone marrow lesions? Professor Kwee Yong: Treatment is very difficult when extra-bone marrow lesions have progressed. In terms of experience, even if the reaction appeared, it did not last very long. I will choose a combination treatment based on proteasome inhibitors and IMiD, an immunomodulatory anticancer drug. Even when extra-bone marrow lesions progressed, there were cases in which the response was very good with IRd treatment. Professor Eom Hyun-seok: In the case of early recurrence, there may be characteristics of high-risk groups, and if the response appears slowly while presenting the case, the duration of the reaction will be extended. Is there anything additional to say about the reaction time and timing of recurrence? Professor Kwee Yong: First of all, I would like to tell you that there is not only one type of high risk of disease. Some high-risk factors speed up disease progression and respond quickly. Some patients with chromosome defects 17 are thought to have a single opposing genetic effect. The important thing is that treatment should be maintained. If treatment is stopped, it does not work. In some high-risk patients, such as chromosome 1 acquisition or chromosome 17 defect, it takes a long time to respond, but if treatment continues, it will be maintained well. Professor Eom Hyun-seok: In the case of the high-risk patients, it is important to continue treatment. Professor Kwee Yong: So the advantage of IRd is that it can continue to treat proteasomes inhibitors. It is difficult in VRd or KRd. Professor Eom Hyun-seok: Another part is about clinical practice. There are a variety of important clinical trials related to secondary treatment, which are slightly different from real world data, so you should be careful in interpreting these data. Professor Kwee Yong: There are several clinical trials and the number of previous treatments varies from one to three. However, most of the large-scale clinical trials were conducted before Lenalidomide was widely used. These clinical trials are not very useful these days because the proportion of patients exposed to lenalidomide was small and they were not refractory to lenalidomide. This is especially true if the patient has already received lenalidomide treatment. Clinical trials have shown good results for Renalidomide three-drug therapy such as Daratumab-Lenalidomide-Dexamethason, KRd, and IRd. However, when looking at the meta-analysis data, the margin benefit is similar. In addition, these clinical trials exclude many patients with poor performance data, patients with renal dysfunction, and patients with low platelet levels that we meet at the clinic every day. Professor Eom Hyun-seok: In Real World, it is very important whether the drug resistance or treatment continues. For patients, discontinuation of treatment is not the best, but I think excellent drug resistance is one of the biggest advantages of IRd.
- Company
- Expectations rise for Rinvoq in treating severe AD
- by Nov 10, 2021 05:55am
- A second JAK inhibitor has been introduced to the field of moderate-to-severe atopic dermatitis treatment. Abbvie’s ‘Rinvoq (upadacitinib),’ with its double advantage in improved convenience and effect, is heralding new change in the field of AD treatment. Rinvoq was additionally approved for the atopic dermatitis indication on the 6th last month by the Ministry of Food and Drug Safety. With the approval, Rinvoq is now approved for patients with moderate-to-severe atopic dermatitis in adults and adolescents over the age of 12. Rinvoq became the second JAK inhibitor after ‘Olumiant’ to be approved for atopic dermatitis. Also, the addition of Rinvoq increased the number of options for AD to three – the biological drug ‘Dupixent,’ and JAK inhibitors Rinvoq and Olumiant – in an area where no new drug had been introduced for a long period of time. ◆Dupixent’ targets specific cytokines – ‘Rinvoq’ provides broader inhibition Numerous inflammatory mediators are entangled like a web in atopic dermatitis, and Dupixent and the JAK inhibitor Rinvoq treat atopic dermatitis with different mechanisms of action. Dupixent selectively and potently inhibits IL-4 and IL-13, the key and central drivers of the type 2 inflammation that causes atopic dermatitis. It provides a higher effect by targeting specific cytokines, but also may not be effective in some patients. On the other hand, JAK inhibitors including Rinvoq provide broader cytokine inhibition. Cytokines bind to the cell surface receptors to deliver signals through the JAK-STAT and other signaling pathways, and JAK inhibitors target the JAK enzymes that command the protein that plays a pivotal role in immune/inflammatory regulation. Among the JAK enzymes, Rinvoq specifically targets JAK1, which not only includes IL-4 and IL-13, but also is involved in various other cytokines including the itch-specific cytokine IL-31, keratin-involved TSLP, IL-22 that thickens the skin, and interferon-gamma. ▲ Yong-hyun Jang, Professor of Dermatology at Kyungpook National University College of Medicine This mechanism of action is how RInvoq was able to show immediate effect in such a short period of time. At the RInvoq press conference that was held on the 9th, Yong-Hyun Jang, Professor of Dermatology at Kyungpook National University College of Medicine, said, “Inhibiting only IL-4 and IL-13 cannot be a complete solution to atopic dermatitis, as the immunopathological mechanism of atopic dermatitis is very complex, and manifests differently by race or age. The introduction of Rinvoq has resolved this unmet need.” Also, another difference between the two drugs that arise from the differences in mechanisms is in their method of administration. The biologic Dupixent is an injection and JAK inhibitors like RInovq are small molecule inhibitors that can be taken orally. Rinvoq can be a more convenient option for patients who have difficulty making regular visits to hospitals for injections. Oral drugs also have the advantage of allowing easier dosage adjustments fit for each patients’ condition. ◆Rises among JAK inhibitors with its superior data… achieves convenience in administration and effect Another advantage of Rinvoq is its excellent clinical data. In Phase III studies that compared RInvoq with placebo (Measure Up1, Measure Up2, AD Up), 60~70% of patients who received Rinvoq achieved EASI75 (at least a 75% improvement in the Eczema Area Severity Index) at Week 16. The proportion was 70-80% in patients who receive a higher dose (30mg). Also, 42-53% (higher dose 58-66%) achieved EASI90 (at least 90% improvement). Also, RInvoq significantly reduced itching, the symptom patients find most difficult to bear, in about half of the patients. 42~53% (Worst Pruritus improvement≥4) The results were more positive than the data from Olumiant, where about half of phase 3 participants reached EASI75. In addition, Rinvoq also demonstrated superior efficacy and safety in a head-to-head trial compared to Dupixent, which has the sole lead in treating moderate-to-severe atopic dermatitis. In the 3b Heads Up study, 71.0% of patients treated with Rinvoq achieved EASI 75 at week 16, which was higher than the 61.0% in the Dupixent-treated group ▲ Dong-hoon Lee, Professor of Dermatology at Seoul National University HospitalAlso, recently updated analysis data shows that switching from dupilumab to RInvoq had shown significant improvement. Dong-hoon Lee, Lee of Dermatology at Seoul National University Hospital, said, “Both the patients who showed response or no response to dupilumab showed significant improvement when switching from dupilumab to Rinvoq at Week 24 or later. And the effect continued until Week 52. The significant improvement in skin clearance and itching reduction even after switching was notable.”
