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- 2025-12-23 07:50:53
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- Cosentyx is approved for hidradenitis suppurativa
- by Eo, Yun-Ho Nov 03, 2023 05:32am
- 'Cosentyx' has entered the field for hidradenitis suppurativa where no other treatment option than ‘Humira’ had been available until now. Moreover, the company plans to immediately enter the market for the indication in Korea as well. According to industry sources, Novartis Korea recently submitted an application to the Ministry of Food and Drug Safety to extend the indications for its interleukin (IL)-17A inhibitor Cosentyx (secukinumab) to hidradenitis suppurativa (HS). Considering how the indication was approved by the US FDA on the 1st, the company is rapidly preparing to introduce the treatment to Korea. Cosentyx is the first interleukin inhibitor to receive approval for the hidradenitis suppurativa indication and is an achievement made in 10 years after Humira (adalimumab). Hidradenitis suppurativa is characterized by pain and skin lesions such as subcutaneous nodules, abscesses with sinus tract formation, and scars. Repeated inflammation and pus can cause odor, interfering with daily life and adversely affecting the patient’s quality of life. Hot and humid weather makes these symptoms worse, and when the initial inflammation and subcutaneous nodules worsen, sinus tracts can form to the inside of the skin and cause scarring. Its prevalence, which is around 0.00033-4.1% worldwide, has been increasing gradually. According to data from the Health Insurance Review and Assessment Service, about 10,000 patients were reported with hidradenitis suppurativa in Korea as of last year, but the actual number is estimated to be greater. Studies in North America and Europe showed that it occurs more commonly in women, but in Korea, it occurs more commonly in men. Cosentyx's approval was based on the results of the SUNSHINE and SUNRISE trials, which were the largest Phase III clinical trials conducted in the field of hidradenitis suppurativa. Study results showed that the proportion of patients who achieved clinical response (HiSCR50) for hidradenitis suppurativa was higher in the Cosentyx 300mg arm than in the placebo arm when administered every 2 or 4 weeks. Cosentyx for hidradenitis suppurativa is administered at a dose of 300 mg every 4 weeks, and the dose can be increased every 2 weeks if the patient shows inadequate response. In the SUNSHINE study, the percentage of patients achieving HiSCR was 44.5% in the Cosentyx arm, compared to a mere 29.4% in the placebo arm. The HiSCR achievement rates in the SUNRISE study were 38.3% and 26.1%, respectively. In addition, the Cosentyx 300mg 4-week treatment arm also showed a significantly higher HiSCR achievement rate than the placebo arm. In the SUNSHINE study, the HiSCR achievement rate in the Cosentyx 300mg 4-week treatment arm was 41.3%, but 29.4% in the placebo arm. In the SUNRISE study, the rates were 42.5% and 26.1%, respectively. In addition, as a result of exploratory analysis up to 52 weeks of treatment, the HiSCR rate of the Cosentyx arm was sustained through week 52 of the study.
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- Novartis Jakabi expands graft-versus-host disease coverage
- by Nov 02, 2023 05:35am
- Novartis Korea announced that Jakabi, a Janus Kinase (JAK) inhibitor, will be covered by insurance for the treatment of acute or chronic graft-versus-host disease from November 1. About 1 year and 6 months after Jakabi was approved for graft-versus-host disease indication in May of last year, insurance benefits were applied to patients aged 12 or older who did not respond sufficiently to previous corticosteroid treatment. Graft-versus-host disease is a disease that occurs after allogeneic hematopoietic stem cell transplantation when the donor's T cells recognize the patient's normal cells as foreign substances. A variety of symptoms appear across multiple organs and greatly reduce the patient's quality of life. Steroids are used as the first treatment, but there is a risk of various side effects. In addition, about half of patients do not respond to treatment and show dependence on steroids, which reduces the effectiveness of treatment. Jakabi is a targeted treatment that selectively inhibits JAK hyperactivity signals and acts on both JAK1 and JAK2, the main causes of inflammation and tissue damage in graft-versus-host disease. Jakabi acts as a mechanism to lower the excessive production of inflammatory cytokines that cause tissue damage in graft-versus-host disease and to suppress the expansion of T cells. Jakabi has proven its effectiveness in patients with acute graft-versus-host disease refractory to corticosteroids through REACH2,3 clinical studies. Kim Hee-je, a professor at Seoul St. Mary's Hospital (Department of Hematology), said, "Patients with hematological diseases who have suffered from severe acute or chronic graft-versus-host disease that occurs after allogeneic hematopoietic stem cell transplantation have not been able to establish a standard treatment after the failure of primary steroid treatment, so there is no effective treatment available. “There was no such thing,” he said. The professor added, "Jakabi's listing on the payroll means that for the first time, a treatment that will solve the unmet need for treatment that has not been addressed in Korea has been prepared for the first time, and at the same time, patients can receive effective treatment without financial burden." Lee Ji-Yoon, managing director of Novartis Korea's Blood and Oncology Division, said, "We are pleased that this reimbursement listing has laid the foundation for domestic graft-versus-host disease patients to receive treatment comfortably without financial burden." Managing Director Lee said, “We will continue to strive to provide better treatment opportunities for domestic graft-versus-host disease patients and create an environment where they can focus solely on treatment.”
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- Reblozyl can be prescribed in general hospitals in KOR
- by Eo, Yun-Ho Nov 02, 2023 05:35am
- Reblozyl, a treatment for myelodysplastic syndrome, can now be prescribed in general hospitals in Korea. According to industry sources, BMS Korea’s Reblozyl (luspatercept-aamt) passed the drug committees (DCs) of several medical institutions in Korea including Samsung Medical Center and Sinchon Severance Hospital. Reblozyl is indicated to treat anemia in patients who showed inadequate response to or are intolerant to treatment with an erythropoiesis-stimulation agent (ESA) who have ▲ very low- to intermediate-risk myelodysplastic syndrome with ring sideroblasts (MDS-RS), or ▲ very low- to intermediate-risk myelodysplasia/myeloproliferative tumor with ring sideroblastic cells and thrombocytosis, or ▲myeloproliferative neoplasm with ring sideroblasts and thrombocytosis, or ▲ anemia in adult patients with beta-thalassemia who require regular red blood cell (RBC) transfusions. The starting dose is 1.0 mg/kg subcutaneously once every 3 weeks for myelodysplastic syndrome and beta-thalassemia. Reblozyl has a mechanism of action that induces red blood cell maturation by inhibiting hyperactivation of the Smad 2/3 pathway caused by TGF-β superfamily ligands. Reblozyl demonstrated efficacy in the Phase III MEDALIST trial. Study results showed that the proportion of patients in the placebo arm who achieved continuous blood transfusion (transfusion independence) for at least 8 consecutive weeks during the 24-week observation period was only 13% while 38% in the Reblozyl arm reached 38%. During the same period, the rates of achieving transfusion independence were 8% and 28% respectively for 12 weeks or longer, and 4% and 19% respectively, for 16 weeks or longer in the placebo and Reblozyl arm, When extending the period to 48 weeks, only 7% of patients in the placebo arm achieved transfusion independence for longer than 16 weeks, whereas in the Reblozyl arm, the rate was 28%. Meanwhile, myelodysplastic syndrome is a malignant disease that occurs in hematopoietic cells in the bone marrow. It is a geriatric disease whose incidence increases rapidly in people over 60 years of age. It is characterized by ineffective and dysplastic hematopoiesis in the bone marrow and a decrease in normal white blood cells, red blood cells, and platelets in the peripheral blood. The most common symptoms include fatigue, general weakness, and decreased exercise capacity due to anemia. In severe anemia, symptoms such as palpitations, shortness of breath, and chest pain may also appear and develop into acute myeloid leukemia. Due to different clinical manifestations and course of the disease in each subcategory, some people live stably for decades with only mild anemia, but others develop complications due to a decrease in red blood cells or develop acute leukemia and die within a few months.
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- Public petition filed for the reimb of Verzenio
- by Eo, Yun-Ho Nov 02, 2023 05:35am
- A public petition imploring the government to reimburse Verzenio for early breast cancer has been posted online for review. On October 31st, a petition was posted on Cheong Wa Dae’s National Petition Bulletin Board entitled ‘Petition requesting reimbursement for Verzenio (abemaciclip), a targeted treatment for early breast cancer.’ The petitioner introduced himself as a person whose wife is suffering from HR+/HER2- breast cancer and asked the government to promptly list Verzenio, which is virtually the only treatment option available for her condition, for reimbursement. Accordingly, attention is focused on whether the CDK4/6 inhibitor Verzenio, which recently reapplied for reimbursement after a failure, will be able to successfully be reimbursed. Apart from letrozole generics that are used as endocrine therapy, Verzenio is the only new drug for the HR+/HER2- subtype of breast cancer. The drug was first approved on November 18th, 2022 as an adjuvant treatment for adult patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-), node-positive, early breast cancer (EBC) at high risk of recurrence in combination with endocrine therapy. More specifically, a very limited range of patients with ▲ 4 or more positive axillary lymph nodes, ▲ 1-3 positive axillary lymph nodes, and a tumor size of 5 cm or larger, or ▲histological grade 3 disease, can receive treatment with Verzenio. Lilly applied for reimbursement immediately upon Verzenio‘s approval. However, the drug struggled from the first step to its reimbursement at HIRA's Cancer Disease Review Committee level. After a long wait of 6 months after submitting the application, the agenda was finally reviewed at the 3rd CDDC meeting that was held on May 3rd. However, Verzenio had unfortunately many contestants. A total of 9 items were reviewed in the 3rd CDDC meeting. This was the largest amount of subjects among the 7 cancer screening meetings held this year. Five months after the first CDDC review, Lilly filed for reimbursement again on October 4th to the Health Insurance Review and Assessment Services. The company was equipped with new supporting data presented at the 2023 ESMO Congress that had been held in Madrid, Spain recently. The 5-year morachE data that was released was a follow-up study of the 4-year data released at the San Antonio Breast Cancer Symposium published in Lancet Oncology in December 2022. Study results showed that the differences in the major clinical indicators - invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) rates – widened more distinctively between the Verzenio arm and the control arm (endocrine therapy alone) at 5 years compared to 4 years. At 5 years, the primary efficacy endpoint IDFS differed by 8%. This means that even after completing Verzenio treatment during the limited period of 2 years after surgery, its treatment effect continued until the 5th year. This data is even more significant as the term, ‘cure,’ is generally used 5 years after cancer treatment.
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- Daewoong-Merck pursues full-cycle AI-based new drug dev
- by Lee, Seok-Jun Nov 01, 2023 05:40am
- Daewoong Pharmaceutical announced on the 31st that it had signed a memorandum of understanding (MOU) with Merck Life Science for the ‘establishment of an AI-based new drug development platform and full-cycle technical support of new drug development.’ The companies will work together to improve the efficiency and productivity of the new development process. Under the MOU, Merck will provide the data and programs necessary for the drug development process, and Daewoong will incorporate them into its web-based modeling platform for drug candidate discovery, verification, and monitoring. Merck will become the first in the industry to use AI (artificial intelligence) to support the technology necessary for the ‘entire cycle’ of new drug development. Daewoong Pharmaceutical will utilize Merck’s ‘SYNTHIA™’ and 'AMS(Aldrich Market Select)’ to improve the efficiency of its drug development process. Daewoong Pharmaceutical has demonstrated its R&D capabilities by developing new homegrown drugs for 2 consecutive years, including the gastroesophageal reflux disease treatment 'Fexuclue' and the SGLT-2 inhibitor antidiabetic ‘Envlo.’ Through the MOU, the company plans to strengthen its competitiveness in R&D and spur the development of first-in-class global blockbuster drugs. Joon-Seok Park, Park Chief of Daewoong Pharmaceutical's Drug Discovery Center, said, “We expect the MOU to increase our efficiency in new drug research and lay the foundation for our growth into a global big pharma by widening the gap in our new drug R&D capabilities with other domestic competitors. Ji Young Chung, Head of Science and Lab Solutions at Merck Life Science, said, “Our MOU with Daewoong Pharmaceutica holds significance as it marks the first partnership in Korea forged to support AI-based drug development throughout its entire lifecycle.”
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- 5th JAK inhibitor released…heats up competition
- by Kim, Jin-Gu Nov 01, 2023 05:40am
- (clockwise from the upper left) Jyseleca, Cibinqo, Rinvoq, Olumiant, Xeljan The fifth product was released in the market for JAK inhibitors, an oral autoimmune disease treatment drug. The JAK inhibitor market, which has continued rapid growth recently, is expected to grow more rapidly due to the addition of the new product. Competition among products is also expected to intensify. While Olumiant (baricitinib), Xeljanz (tofacitinib), and Rinvoq (upadacitinib) are competing for the lead, the new entrants, Cibinqo (abrocitinib) and Jyseleca (filgotinib), are also heralding their pursuit. Quarterly prescriptions exceed KRW 10 billion… Olumiant, Xeljanz, Rinvoq in a fierce battle for the lead Industry sources revealed that Eisai Korea released Jyseleca on the 1st. With the addition of Jyseleca, a total of 5 JAK inhibitors are currently available in the Korean market. Following the release of Pfizer Xeljanz in 2015, Lilly’s Olumiant was released in 2019, and AbbVie’s Rinvoq in 2021. In July this year, Pfizer's second JAK inhibitor, Cibinqo, was launched, and then Eisai’s Jyseleca. JAK inhibitors are used for autoimmune diseases such as rheumatoid arthritis and atopic dermatitis. Its mechanism of action blocks inflammation, pain, and cell activation by suppressing inflammatory cytokines. The domestic JAK inhibitor market has been expanding rapidly. According to the pharmaceutical market research institution UBIST, outpatient prescriptions of domestic JAK inhibitors in Q3 this year reached KRW 10.7 billion, a 24% increase in a single year compared to the KRW 8.6 billion made in the same period last year. In particular, quarterly prescriptions exceeded KRW 10 billion for the first time in Q3. At this pace, the total outpatient prescriptions this year are expected to expand and exceed KRW 40 billion. Quarterly outpatient prescription of JAK inhibitors (Unit: KRW 100 million, Data: UBIST) The battle for the lead is also fierce. While sales of Xeljanz, which has kept the lead for a long time, have slowed down somewhat, Olumiant has jumped to the lead since Q2 this year. In Q3, Olumiant posted prescriptions worth KRW 3.7 billion. This is a 28% increase from the KRW 2.9 billion in Q3 last year. During the same period, Xeljanz’s prescriptions increased by 2% from KRW 3.6 billion to KRW 3.7 billion. However, the difference between Olumiant and Xeljanz prescriptions is less than KRW 40 million in Q3, making it unclear which will rise to the top again. On top of that, the third entrant Rinvoq, has also quickly increased its prescription performance and joined in the leading competition. In the third quarter, Rinvoq posted prescriptions worth KRW 3.1 billion. This is a 45% YoY increase from the KRW 2.1 billion posted in Q3 last year. fifth drug ‘Jyseleca’ is released…JAK inhibitor market expected to continue to grow The addition of Cibinqo and Jyseleca to the market is expected to further intensify competition in the JAK inhibitor market. Cibinqo was released with reimbursement in July to treat atopic dermatitis. In the first 3 months of its launch, prescription sales amounted to approximately KRW 260 million. Jyseleca was newly released on the 1st of this month. It is an adenosine triphosphate (ATP)-competitive and reversible inhibitor that selectively inhibits JAK1. Quarterly major JAK inhibitor prescriptions (Unit: KRW 100 million, Data: UBIST) The JAK inhibitor market is expected to continue its high growth for some time due to the expansion of indications and the addition of new products. After first receiving approval as a treatment for rheumatoid arthritis, Xeljanz additionally received indications for psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. Olumiant first received approval as a treatment for rheumatoid arthritis, then added indications for atopic dermatitis and alopecia areata. Rinvoq was also first approved for rheumatoid arthritis and then added indications for psoriatic arthritis, ankylosing spondylitis, atopic dermatitis, and ulcerative colitis. Cibinqo indicates atopic dermatitis. However, unlike other products, it can be used not only by adults but also by teenagers over the age of 12. The fifth product, Jyseleca, has indications for rheumatoid arthritis and ulcerative colitis.
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- Gilead aims for reimbursement of COVID-19 tx Veklury
- by Eo, Yun-Ho Nov 01, 2023 05:40am
- COVID-19 treatment Veklury is aiming to be listed on insurance benefits. According to related industry sources, Gilead Sciences Korea submitted an application for Veklury's benefit last month. As with Pfizer Korea's Paxlovid, the government plans to end the current free support system from the first half of next year, so it is believed that the reimbursement registration process will be followed accordingly. The government announced that it will pursue the registration of Paxlovid insurance benefits within the first half of 2024 in accordance with the plan to ease the COVID-19 crisis level adjustment roadmap. This measure is due to the fact that COVID-19 treatments, which are currently being supplied free of charge, are about to be converted to being supplied for a fee like general medicines. When stage 2 of the COVID-19 crisis level adjustment roadmap, which further relaxes the quarantine system, is implemented next month, COVID-19 will transform into a level 4 infectious disease like influenza (flu). In other words, the incorporation of medicines such as Veklury and Paxlovid into the general medical system becomes inevitable. The government said that even if the second stage roadmap is implemented, it will provide oral COVID-19 treatments free of charge for the time being, but it is unclear how long the free provision will last. Meanwhile, Veklury has a wider range of indications than Paxlovid. This drug was first approved in Korea in July 2020, and based on the current indications, it can be prescribed for children and adults, from mild to moderate patients at high risk of progressing to severe disease to patients with severe pneumonia requiring supplemental oxygen treatment. do. Gilead's application for reimbursement was also made for all currently approved indications for Remdesivir.
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- Global biosimilar market worth KRW 3.9 tril…Pfizer vs Amgen
- by Kim, Jin-Gu Oct 31, 2023 05:35am
- Prospects of the global biosimilar market have shown that the global biosimilar market, which is currently worth USD 28.62 billion (about KRW 39 trillion), will expand rapidly to reach USD 76.51 billion (about KRW 102 trillion) by 2028. On the 30th, the Korea Biotechnology Industry Organization made the forecast, citing biosimilar market data from global market research firm Frost & Sullivan (F&S). According to KoreaBIO, the global biosimilar market is expected to grow 17.8% a year until 2028. In particular, market size is expected to grow in earnest with the release of Humira (adalimumab) biosimilars this year. The global market size is expected to expand to USD 42 billion by next year, to USD 50 billion in 2025, to USD 60 billion in 2027, then to USD 70 billion in 2028. This is because the patents of global blockbuster drugs will be successively expiring during the period. The patents for Eylea, Stelara, Victoza, and Humira will expire this year, the patents for Xolair and Simponi in 2024, the patents for Prolia, Soliris, and Yervoy in 2025, the patents for Perjeta and Cyramza in 2026, then the patents for Trulicity in 2027. In 2028, patents for Keytruda, Opdivo, and Cosentyx are also set to expire. Currently, more than 400 companies are competing in the global biosimilar market. As of last year, the top 5 companies' share in the global biosimilar market reached 22.1%. Pfizer accounts for 8.4%, Amgen 4.9%, Eli Lilly 3.6%, Biogen 2.7%, and Teva 2.6%. In addition, Merck, Boehringer Ingelheim, Fresenius Kabi, Sandoz, Mylan, Biocon, Novo Nordisk, Celltrion, and Samsung Bioepis are competing with the top 5 companies in the North American and European markets. In the largest markets - the US and Europe - 40 and 64 biosimilars were approved, respectively, as of last year. In the case of Humira biosimilars that are attracting attention, 9 of the 10 companies that received approval released their biosimilar products in the U.S. market. In Europe, 10 companies have received approval for their Humira biosimilars. In Europe, in addition to Humira, biosimilar competition is fierce for Avastin (bevacizumab), Neulasta (pegfilgrastim), and Neupogen (filgrastim). 8 companies were approved for their Avastin and Neulasta biosimilars, and 7 companies were approved for their Neupogen biosimilars. Korea and Japan are leading the biosimilar approval and manufacturing in the Asian market, with India and China rapidly catching up. India has the most number of approved biosimilars in the world, with the count currently at 127. This surpasses the number of those approved in Germany and the United States. China has also emerged as a major country in biosimilar R&D recently. Currently, more than 60 pharmaceutical companies in China are developing biosimilars.
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- Public opinion grows on if PO kidney tx should be covered
- by Nho, Byung Chul Oct 31, 2023 05:35am
- Bayer chronic kidney disease treatment Kerendia. This drug is a disease-related disease that has emerged for the first time in 20 years As first-in classes related to kidney disease are blocked by insurance registration review barriers, it seems urgent to improve the system through social consensus. A drug related to this is Kerendia, Bayer's chronic renal failure treatment that was newly introduced for the first time in 20 years. Renal anemia that occurs due to abnormal kidney function can be mentioned, including the recently approved AstraZeneca Evrenzo (2021), JW Pharmaceutical Eronai (2022), and Mitsubishi Danabe Vadanem (2023). The reasons why a rapid registration process for innovative new drugs related to kidney disease is required are to expand patient treatment options and reduce health insurance finances. According to the NHIS data, the number of chronic kidney disease patients in Korea increased by 36.9% from 206,061 in 2017 to 282,169 in 2021, and in particular, those in their 80s surged by 82.8%. The number of hemodialysis patients is also showing an exponential increase, and the health insurance budget currently spent on approximately 100,000 patients is close to 3 trillion won. Compared to existing renal anemia treatments that are distributed only as injections, it is expected that patient compliance will also significantly increase because it is in the form of an oral pill. The news that Kerendia has been submitted to the pharmaceutical review committee provides some hope for the insurance listing of these drugs related to comprehensive kidney disease. This is a result of approximately one and a half years after approval (May 2022) due to the expression of opinions from all directions, including not only the developer, but also the nephrology society, the National Assembly, and patient groups. Therefore, discussions on drug price negotiation for Kerendia, which was recognized as appropriate for coverage of chronic kidney disease with type 2 diabetes at the 11th pharmaceutical reimbursement evaluation committee, are gaining momentum, giving strength to the justification for listing renal anemia treatment drugs. The reason why health authorities actively reviewed the adequacy of Kerendia's benefits was to reduce social costs. When chronic kidney disease progresses to end-stage renal failure, treatment progresses to hemodialysis, peritoneal dialysis, kidney transplantation, and surgery, which costs around 30 million won per year, which goes against public opinion to overcome this by actively intervening in drug therapy in the process. We are doing it together. AstraZeneca, JW Pharmaceutical, and Mitsubishidanabe obtained approval from the Ministry of Food and Drug Safety for tablet-type renal anemia treatments Evrenzo, Eronai Tablet, and Badanem in 2021, 2022, and 2023, respectively. These drugs are expected to have equivalent effects compared to injectable drugs and contribute to reducing health insurance costs but are still pending HIRA review As can be seen in the Kerendia case, tablet-type renal anemia treatments also require an emphasis on drug efficacy and cost-effectiveness and a quick reimbursement process is required. It is known that tablet-type renal anemia treatment drugs can achieve financial savings of about 10 to 20% compared to existing injection drugs, based on clinical data on anemia treatment in dialysis patients, even if patients with general kidney disease are excluded. Some are concerned about issues related to blood clots, but according to the industry, existing drugs appear to be in a similar situation, so it is almost a logical contradiction to use this as an issue to put a brake on drug price negotiations. The only treatment for renal anemia is EPO, which was developed about 30 years ago, and recently, even third-generation injectable drugs with extended administration intervals have been released. As the number of patients who do not respond to existing medications is gradually increasing, new treatment mechanisms are required due to side effects such as blood pressure changes and nausea and vomiting. It is understood that JW Pharmaceutical's Eronai and Mitsubishi Badanem are attempting to be listed at the average price among alternative drugs. AstraZeneca Evrenzo appears to have virtually suspended all proposals for PE and alternative drug weighted average prices based on the headquarters' high orphan drug price policy.
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- Zavicefta nears final negotiations for reimb in KOR
- by Eo, Yun-Ho Oct 31, 2023 05:35am
- Whether the next-generation antibiotic ‘Zavicefta’ will be successfully listed for reimbursement is gaining attention. Under the Ministry of Health and Welfare’s order to proceed to drug pricing negotiations, Pfizer Korea is soon set to begin pricing discussions for ‘Zavicefta’ (ceftazidime-avibactam). The drug passed the Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee review last September. However, unlike other drugs that almost immediately started negotiations, the company wasn’t able to start drug pricing negotiations for the drug right away. With the negotiations soon to begin, it remains to be seen whether a new antibiotic drug will be listed in an area where no other drug than MSD Korea's Zerbaxa (ceftolozane-tazobactam) has brought results. Zavicefta was developed to address the urgent need for new antibiotics in severe infections that cause serious problems such as multidrug-resistant pseudomonas aeruginosa or carbapenem-resistant gram-negative Enterobacteriaceae and extended-spectrum-lactamase (ESBL) producing intestinal bacteria. Zavicefta is used to treat adult patients suffering from complicated intra-abdominal infections (cIAI); complicated urinary tract infections (cUTI), including pyelonephritis; hospital-acquired pneumonia (HAP); and the treatment of aerobic Gram-negative infections in adult patients who have limited treatment options. Zavicefta was originally developed by AstraZeneca. In 2016, Pfizer acquired the drug while acquiring AstraZeneca’s antibiotic business. Securing a new treatment alternative for carbapenem is a global health issue publicized by the WHO. Multidrug-resistant Gram-negative bacteria are increasing worldwide and have recently become a serious problem in healthcare-associated infections. This is why the WHO had designated carbapenem-resistant Pseudomonas aeruginosa as a Priority 1: Critical pathogen that requires research and development of new antibiotics. Korea’s pseudomonas aeruginosa resistance rate to carbapenems is 30.6%, the second highest among the surveyed countries after Greece. Also, the ESBL (extended-spectrum beta-lactamases)-producing Enterobacteriaceae are also showing resistance to cephalosporin antibiotics that are effective against a wide range of gram-negative bacteria. Currently, new antibiotics available in Korea include MSD’s anti-infective Zerbaxa (ceftolozane-tazobactam) and Pfizer’s antifungal ‘Cresemba (isavuconazonium).’
