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- 2026-05-04 18:38:50
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- "Active viral hepatitis treatment can prevent carcinoma"
- by Son, Hyung-Min Jul 26, 2024 05:47am
- Maria Buti, Chair of Public Health at the European Association for the Study of the Liver (EASL) "Most individuals affected by viral hepatitis do not have symptoms. They may not be aware of their infection. When individuals realize that they have abnormalities in their body, liver disease has already progressed. It is important to identify and treat patients early in their disease progression to prevent complications related to hepatocellular carcinoma and liver disease." During a meeting with Daily Pharm, Maria Buti, Chair of Public Health at the European Association for the Study of the Liver (EASL), emphasized the importance of early treatment for hepatitis B and hepatitis C. Hepatitis B is caused by hepatitis B virus (HBV). It can cause infection, advanced liver injury, and chronic liver disease. Hepatitis B is implicated in the cause of hepatocellular carcinoma by over 60%. Recently, there has been a discussion about maximizing the preventative effect of hepatocellular carcinoma by early treatment of hepatitis B. Vemlidy is indicated for treatment. Compared to the conventional use of TDF (tenofovir disoproxil fumarate), such as Viread, Vemlidy has been shown to reduce the occurrence of hepatocellular carcinoma by half. Hepatitis C is identified as contributing to the occurrence of hepatocellular carcinoma in 10-15% of the patients. However, hepatitis C is now curable with the introduction of Epclusa. There are various genotypes of hepatitis C, and Epclusa is highly effective in most patients, regardless of their genotypes. Buti emphasized the timely use of treatments to prevent hepatocellular carcinoma now that effective new drugs are available. Vemlidy has been shown to be effective in preventing hepatocellular carcinoma Because Hepatitis B is incurable, individuals must take medicines their whole lives, but treatments for managing the virus are available in the market. Vemlidy, a type of TAF (tenofovir alafenamide), Vemlidy, and Baraclude are used to treat hepattiis B. Currently, the drugs used in clinical practice are known to suppress viral load significantly. These treatments can suppress the virus to an undetectable level in tests, even though the virus continues to attempt replication. "Antiviral drugs such as Vemlidy, Viread, and Baraclude can help prevent liver decompensation in patients," Buti said. "However, ensuring the safety of drugs is increasingly important due to their long-term use." Vemlidy is also suitable for use in pregnant women and has the advantage of not requiring dose adjustment based on the patient's renal function status. The 8-year follow-up clinical trials, 'Studies 108 & 110,' for Vemlidy conducted on both treatment-naive and treatment-experienced patients, confirmed 5-year viral suppression rates and liver cancer prevention effects. Out of the 1,298 patients involved in the study, there were no instances of decompensated hepatocirrhosis reported in the Vemlidy-treated group. Moreover, during the 8-year period, there were 21 cases (1.6%) of hepatocellular carcinoma in the Vemlidy-treated group. There were also no documented cases of drug resistance among patients treated with Vemlidy. In a study evaluating the safety of Vemlidy in patients with severe kidney dysfunction and kidney diseases, no additional adverse reactions were observed. "If active treatment with drugs like Vemlidy is initiated early during hepatitis B infection, favorable outcomes can be achieved," Buti said. "Additionally, it has been shown that Vemlidy can prevent the occurrence of hepatocellular carcinoma and other complications. Currently, treatment trends focus on the early use of TAF-based drugs such as Vemlidy." Buti added, "Korean treatment guidelines, such as those from the Korean Association for the Study of the Liver, have stricter restrictions on the use of drugs compared to European guidelines. In Europe, the criteria for initiating treatment, such as HBV DNA levels or liver function tests, are relatively lower, allowing for earlier treatment initiation." Buti said, "To effectively treat hepatitis B, starting treatment as early as possible for as many patients as possible is crucial. It is necessary to compare different guidelines to broaden the scope of treatment." Hepatitis C, without vaccines…drugs can be used for prevention Hepatitis C has a lower risk of hepatocellular carcinoma compared to hepatitis B, but if left untreated, it can lead to liver cancer or severe liver disease. Hepatitis C is considered curable if detected early and treated with drugs on time. Epclusa has made it possible to treat hepatitis C regardless of genotype or liver cirrhosis status. Buti emphasized, "Hepatitis C has various genotypes, but Epclusa is effective regardless of genotype. Epclusa can be administered orally once daily, making treatment easier for patients." Patient screening is important for Hepatitis B since it's curable, according to Buti. "Spain was the first country in the world to achieve hepatitis C elimination. A key factor in this success was the micro-elimination strategy. While definitions of high-risk groups may vary by country, in Spain, high-risk groups with high hepatitis C prevalence, such as injection drug users and patients with mental illnesses, were required to undergo screening whenever they visited the emergency room," Buti said. In Spain, individuals have participated in screening for hepatitis C, which has led to significant achievements. "Since there is no vaccine for hepatitis C, treatment is used as a preventive measure. From a public health perspective, this is a critical concept," Buti said. "Treating infected individuals to block further virus spread is a good approach to prevention." "When a patient is diagnosed with hepatitis C through screening, it is crucial to provide timely information about appropriate treatments, such as antiviral drugs, and ensure that the treatment is pursued. A diagnosis without follow-up treatment is meaningless. Therefore, linking diagnosis to treatment is crucial for achieving hepatitis C elimination," Buti added. "To prevent viral liver infection from progressing and patients suffering from side effects, early diagnosis of patients is crucial. The only way is to do a screening. This applies to both hepatitis B and hepatitis C," Buti emphasized.
- Company
- Mitsubishi accepts DREC results for Uplizna...nears reimb
- by Eo, Yun-Ho Jul 26, 2024 05:47am
- Mitsubishi Tanabe Pharma’s twice-yearly neuromyelitis optica spectrum disorder (NMOSD) drug Uplizna is headed for reimbursement listing in Korea. According to industry sources, Mitsubishi Tanabe Pharma’s Korea accepted the ‘below the evaluated amount’ condition set by the Health Insurance Review and Assessment Service's Drug Reimbursement Evaluation Committee for the reimbursement of Uplizna (inebilizumab), a treatment used to treat adult patients with for neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-Aquaporin-4 (AQP4) antibodies. As a result, the company will enter pricing negotiations with the National Health Insurance Service in the near future. Uplizna is administered at an initial 300 mg dose, followed by an additional 300 mg dose 2 weeks later, and then every 6 months thereafter from the date of the initial dose. NMOSD occurs when AQP4 autoantibodies, a disease-specific biomarker produced by B cells, bind to AQP4, a target antigen present on glial cells in the central nervous system, and activate the immune responses, causing nerve damage. Uplizna is an anti-CD19 human monoclonal antibody that selectively binds to CD19, a B cell-specific surface antigen, depleting B cells that produce AQP4 antibodies, thereby preventing disease relapse. The safety and efficacy of Uplizna were demonstrated in the N-MOmentum study, which evaluated the use of Uplizna monotherapy in 230 patients without the use of concomitant immunosuppressive agents. Study results showed that 89% of patients treated with Uplizna did not experience a relapse during 197 days of follow-up, resulting in a 77.3% reduction in the risk of relapse compared to placebo. Safety evaluations Uplizna also showed comparable rates of adverse events to the placebo group. Also, in an extension study, Uplizna continued to reduce the risk of relapse for at least 4 years, with an 87.7% relapse-free rate. In terms of long-term safety profile, Uplizna was generally well tolerated, with no increase in infection rates due to B-cell depletion. NMOSD is a serious autoimmune disease in which most patients experience persistent relapses and incomplete recovery, resulting in accumulated nerve damage that can cause vision loss, gait disturbances, and even death from respiratory failure.
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- Guidelines for new obesity drugs must be established
- by Moon, sung-ho Jul 26, 2024 05:46am
- Obesity is projected to impact around 2 billion individuals by 2035. Including overweight, about 4 billion individuals will be affected by obesity, making it a significant global healthcare issue. Following this trend, pharmaceutical and biotech industry is focusing on developing next-generation treatments for obesity. Glucagon-like peptide 1 (GLP-1) drugs, including Saxenda, Wegovy, and Zepbound, showed outstanding weight loss effects in clinical trials. As a result, companies are developing GLP-1-based therapeutics. The number of companies developing obesity drugs by country; big pharmas developing obesity drugs; small businesses and new companies developing obesity drugs. Recently, these drugs have been found to provide cardiovascular benefits and aid weight loss effects. As a result, their expanded use has been gathering attention in clinical settings. The analysis suggests that it's time to consider using these drugs in clinical settings in South Korea. According to drug market research company IQVIA on July 20th, there are 79 obesity drug pipelines worldwide, from preclinical to launched products. Pharmaceutical and biotech companies have developed over 148 products. GLP-1 drugs account for 39% of the pipelines. This suggests that pharmaceutical and biotech companies have begun developing drugs in this class as latecomers after witnessing the success of Saxenda, Wegovy, and Zepbound. 79 obesity drug pipelines worldwide, from preclinical to launched products, and 148 products from pharmaceutical and biotech companies have been developed. The analysis indicates that major companies that have begun developing obesity drugs employ two major development strategies. They either develop a drug as 'monotherapy' based on their differentiation strategy, or consider potential expansion for treating obesity, type 2 diabetes, cardiovascular diseases, and metabolic dysfunction-associated steatohepatitis (MASH) as part of their portfolio strategy. As part of differentiation therapy, monotherapy is being developed to achieve the ▲Highest weight loss rate, ▲Improved safety, and ▲Chronic disease management with oral formulation. For instance, Pfizer and Viking Therapeutics are developing candidate products. Under the portfolio strategy, the market leaders, such as Novo Nordisk (Wegovy) and Lily (Zepbound), and latecomers, aim to expand indications. Lately, the development of 'oral formulation drugs' has gained attention. These drugs are expected to shift the paradigm of a market dominated by injectables. Global companies, Pfizer and Viking Therapeutics, and domestic companies, including Ildong Pharmaceutical and D&D Pharmatech, have started to develop them. Novo Nordisk and Lily, the market-leading companies that already have injectables, have proprietary pipelines. However, Wegovy and Zepbound, which dominate the global market for obesity, have unresolved issue of weight loss rebound. IQVIA Korea's Marketing & Sales Director Kang-Bok Lee said, "Most obesity pipelines at the clinical stage are being developed as oral formulations." Lee added, "However, there are still discussions about oral obesity drugs. Along with the convenience, we must consider whether these drugs are suitable for chronic and maintenance management, and whether their cost and supply network outweigh any remaining issue." Lee added that "There are questions about whether it can have similar efficacy compared to injectables, as well as concerns about tolerability." Lee expressed optimism about oral drug development, saying, "Recently, Viking's oral drug, VK2735, had no clinically significant gastrointestinal side effects compared to placebo, with most being mild." Reflecting on the global trend for obesity drug development, new GLP-1 drugs, such as Wegovy and Zepbound, will likely be introduced to South Korea. According to IQVIA, the market for obesity drugs is rapidly growing after the launch of Wegovy. The worldwide market size in 2023 totaled US$11 billion (about KRW 15.3 trillion), driven by Wegovy. Wegovy contributed 72% of the total US$11 billion-worth market in 2023. In contrast, in South Korea, the release of Wegovy has been delayed due to an issue with 'securing stock' after obtaining marketing approval. As a result, Saxenda (Novo Nordisk) and Qsymia (Alvogen Korea) have taken 60% of the market share, dominating the market. Sources said that the release of Wegovy is set to be released in the Korean market, making it the ninth country globally. A professor from the Department of Endocrinology at an unnamed University Hospital, who is also an executive member of the Korean Society for the Study of Obesity, said, "Following Japan, China has also approved Wegovy. Since an official launch date has not yet been set, it is difficult to guarantee the timing of the release." He analyzed, "This appears to reflect the position of the domestic market within the global market." "Even if it is released, it seems that obesity drugs will be used entirely as non-reimbursable in the domestic market," He added. "While there has been some progress in recognizing obesity as a disease, reimbursement coverage, especially concerning domestic insurance finances, will not be easy." As a result, the pharmaceutical and biotech industries have proposed that, considering the potential of the drug market due to the rising prevalence of obesity, there is a need to accelerate discussions on disease recognition, enhancements in social awareness, and the establishment of clinical practice guidelines and insurance. At the same time, domestic pharmaceutical and biotech companies developing treatments may need to focus on differentiation strategies from competing products, improving efficacy such as preventing weight regain after discontinuation and establishing a stable supply chain to meet global demand. IQVIA Korea's Director Kang-Bok Lee said, "In the past two years, global spending on obesity has increased rapidly with new drugs, and by 2030, more than 15 new items are expected to enter the market, making the next-generation obesity treatment market much more competitive." Lee also said, "Improving educational programs for healthcare professionals to raise awareness of obesity treatment and integrating it into chronic disease management would be an ideal approach." Lee also added, "Currently, even though obesity treatments are approved by the Ministry of Food and Drug Safety (MFDS), there are no cases where these drugs are covered by reimbursement. In the U.S., Medicare (Part D) will now cover Wegovy for some patients with a history of heart disease, as announced by the Centers for Medicare & Medicaid Services (CMS)." Lee added, "In the future, obesity drugs will be divided into reimbursed and out-of-pocket markets, so it is necessary to consider establishing reimbursement criteria for patients with severe obesity or accompanying diseases. We must develop and distribute comprehensive obesity treatment guidelines through collaboration with the medical community and organizations."
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- Antibiotic prescriptions had surged with the pandemic
- by Kim, Jin-Gu Jul 25, 2024 05:51am
- The amount of outpatient antibiotic prescriptions in Korea had changed dramatically during the COVID-19 pandemic. In 2020 and 2021, early stages of the pandemic, antibiotic prescriptions dropped sharply but then surged in 2022. In contrast, the proportion of cephalosporin and quinolone antibiotic prescriptions, which are more powerful than other antibiotics, increased in 2020 and 2021 and then decreased in 2022. The Ministry of Health and Welfare released the "Healthcare Quality Statistics" that contained the above findings on the 24th. The MOHW releases this data annually for comparative statistics among OECD countries. One of the statistical items examines outpatient antibiotic prescriptions in primary care clinics. According to the statistics, in 2022, outpatient prescriptions of local antibiotics, not systemic antibiotics amounted to 21.3DDD per 1000 inhabitants in primary healthcare centers in Korea. Defined Daily Dosage (DDD) is a unit used to measure drug consumption and refers to the average maintenance dose that an adult weighing 70 kg should take per day. Total outpatient antibiotics prescribed for systemic use (Source: Healthcare Quality Statistics 2022) The number of antibiotic prescriptions in Korea has been steadily decreasing since 2016 when it reached 26.9 DDD. Especially during the pandemic, the number dropped below 20.0 DDD in 2020-2021. It is analyzed that as people refrained from outdoor activities due to social distancing measures, respiratory infections decreased, reducing antibiotic prescriptions. In 2022, when the social distancing measures were eased, antibiotic prescriptions made a rebound. From 16.0 DDDs in 2021 to 21.3 DDDs in 2022, the amount increased 33% in 1 year. In contrast, prescriptions for cephalosporin and quinolone antibiotics, which are broader and more potent than other antibiotics, increased significantly early in the pandemic and then decreased near the endemic. Among all outpatient antibiotic prescriptions, the percentage of cephalosporin and quinolone antibiotics increased from 39.5% in 2019 to 43.6% in 2020, then to 44.8% in 2021. In 2022, their share decreased slightly to 43.1%. Percentage of cephalosporin and quinolone antibiotics prescribed (Healthcare Quality Statistics 2022) The prescription and use of antibiotics require management due to resistance issues and is considered one of the important areas to monitor through national antimicrobial resistance management policies. The OECD Healthcare Quality Statistics also includes two indicators related to antibiotics: the total number of outpatient antibiotics prescribed for systemic use and the proportion of cephalosporin/quinolone antibiotics prescribed. The MOHW explained, "The total volume of outpatient antibiotic prescriptions decreased by 34% in 10 years since 2011 due to the strengthening of antibiotic management policies and increased public awareness. However, the proportion of cephalosporin/quinolone antibiotics prescribed for systemic use has continued to increase over the decade and remains high at 43% as of 2022."
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- Meningitis B vaccine Bexsero is released in Korea
- by Moon, sung-ho Jul 25, 2024 05:51am
- Competition in the 'meningococcal' vaccine market, which is mainly vaccinated in pediatric clinics, has recently been reignited. Although its domestic market is worth less than KRW 10 billion, the emergence of next-generation vaccines is expected to spark new competition among multinational pharmaceutical companies. #This is because GSK, the market leader, has launched Bexsero (meningococcal serogroup B vaccine), a next-generation vaccine. Professor Hyunmi Kang (Department of Pediatrics, St. Mary's Hospital, Seoul) explained the clinical implications of the introduction of Bexsero at an event held by GSK on the 16th. Meningococcal meningitis is a statutory Class 2 infectious disease with a fatality rate of approximately 10-14%. It affects 500,000 patients worldwide each year. The main symptoms include headache, fever, neck stiffness, vomiting, and decreased consciousness, and is often accompanied by petechiae or purpura fulminans. 11 to 19% of recovered patients may suffer from sequelae such as hearing loss, cognitive impairment, and neurological disorders, making it an important infection to prevent. In particular, as meningococcal disease is transmitted person-to-person by respiratory droplets or secretions, vaccination is recommended for those who are about to enter a group setting. For example, new recruits and college students who will be living in dormitories may want to consider meningococcal vaccination. Other recommended populations for meningococcal vaccination include travelers and residents of meningococcal endemic areas, such as Africa, and pilgrimage travelers to Mecca, Saudi Arabia. Typical serogroups of meningococci that cause invasive meningococcal infections in humans include A, B, C, W, X, and Y. The most predominant meningococcal serogroup in Korea among these is serogroup B. From 2010 to 2016, the proportion of Meningitis B cases identified in Korea was 28%, but from 2017 to 2020, the rate rose significantly to 78%. In this scene, GSK launched Bexsero, a vaccine that prevents meningococcal serogroup B, in the Korean market 2 years after its approval in 2022. Professor Kang assessed that Bexsero can play a significant role in addressing the unmet need in the field as it prevents meningococcal serogroup B. "Globally, meningococcal infections are most prevalent in infants under one year of age compared to other age groups,” explained Professor Kang. “It causes bacterial meningitis and sepsis, and one to two out of 10 survivors also experience brain damage, hearing loss, and limb loss.” "The prevalence of meningococcal serogroups varies across countries and time periods, so it is not easy to predict. In Korea, serogroup B meningococcal infection cases have increased in recent years, increasing the need for its prevention.” In Korea, GSK is leading the meningococcal vaccine market. The vaccines, which are non-reimbursed, cost KRW 150,000. The first quadrivalent meningococcal vaccine in Korea, GSK’s Menveo has been dominating the market with sales of KRW 5.2 billion based on IQVIA last year. Sanofi's Menactra is also available, but the vaccine only generated KRW 500 million in sales during the same period. In addition, Sanofi received domestic approval for Menquadfi Inj (meningococcal (A, C, Y, W) tetanus toxoid-conjugate vaccine) earlier this year. "In countries such as the United Kingdom, Portugal, and Canada, the importance of preventing disease through immunization has been emphasized due to the high prevalence of meningococcal B," said Joon Bang, Director of Medical Affairs at GSK Korea. "The predominance of meningococcal B in Korea has made it necessary for us to introduce a vaccine to prevent infections caused by meningococcal B.” "We are pleased to be able to contribute to the prevention of meningococcal disease caused by serogroup B, which accounts for a high proportion of meningococcal disease in Korea with the launch of Bexsero. Together with Menveo, the company now owns a vaccine portfolio that can protect against a wide range of serogroups."
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- 'Padcev+Keytruda' combination therapy is set to land in KOR
- by Eo, Yun-Ho Jul 25, 2024 05:51am
- Product photo of Padcev.The combination therapy of 'Padcev+Keytruda,' which is expected to bring a paradigm shift to bladder cancer treatment, will soon land in South Korea. The Ministry of Food and Drug Safety (MFDS) is reviewing the expansion of indication for Astellas Korea's Padcev (enfortumab), an antibody-drug conjugate (ADC), in combination with Keytruda (pembrolizumab), a PD-1 inhibitor that is used in immunotherapy for cancer, as a first-line treatment of urothelial cancer locally advanced or metastatic urothelial carcinoma (la/mUC). The official approval is expected soon. The combination therapy of these drugs for urothelial cancer gained attention after the presentation of its Phase 3 EV-302/KEYNOTE-A39 study results at the 2023 congress of the European Society for Medical Oncology (ESMO Congress 2023), held in October last year, and received a standing ovation. Based on the clinical results, patients treated with Padcev combination had a median progression-free survival (PFS) of 12.5 months, a primary endpoint of the study, indicating a significant improvement compared to the 6.3 months in patients treated with chemotherapy for cancer. Another primary endpoint of the study was median overall survival (OS). The patients had a median OS of 31.5 months, a twofold extension compared to the placebo. Cisplantin-eligible patients treated with Padcev combination had an OS of 31.5 months compared to 18.4 months in placebo-treated group, reducing the risk of death to 47%. Cisplantin-ineligible patients had not reached the median value, whereas the placebo-treated group had an OS of 12.7 months, reducing the risk of death to 57%. In clinical settings, 'Padcev+Keytruda' combination therapy is being considered as a replacement for a first-line treatment GemCis therapy, which has been used as the standard therapy for 30 years. Meanwhile, Padcev was approved in South Korea in March 2023 as a monotherapy for patients with locally advanced or metastatic urothelial cancer who had previous experience with platinum-containing chemotherapy or PD-1 or PD-L1 inhibitors. Astellas has applied for the inclusion of this therapy in reimbursement listing, and it has passed the Cancer Disease Review Committee of the Health Insurance Review and Assessment Service (HIRA).
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- Samsung Bioepis’ Soliris biosimilar is approved in the U.S.
- by Chon, Seung-Hyun Jul 24, 2024 05:51am
- View of the Samsung Bioepis building [데일리팜=천승현 기자] 삼성바이오에피스는 미국 식품의약품국(FDA)으로부터 희귀질환치료제 ‘에피스클리’의 품목허가를 획득했다고 23일 밝혔다. 에피스클리는 미국 알렉시온이 개발한 솔리리스의 바이오시밀러 제품이다. 에피스클리는 발작성 야간 혈색소뇨증, 비정형 용혈성 요독 증후군의 치료제로 FDA 승인을 받았다. 삼성바이오에피스는 2019년 7월부터 2021년 10월까지 발작성 야간 혈색소뇨증 환자들을 대상으로 임상 3상을 통해 에피스클리와 오리지널 의약품 간 비교 연구를 수행했다. 유관 학술대회 발표를 통해 임상의학적 동등성을 입증했다. 삼성바이오에피스는 지난해 7월 에피스클리를 유럽에 출시했고 독일, 이탈리아 솔리리스 바이오시밀러 시장 점유율 1위 등의 성과를 내고 있다. 국내에서는 지난 4월부터 삼성바이오에피스가 직접 에피스클리를 판매하고 있다. 삼성바이오에피스는 오리지널 의약품의 약가 대비 절반 수준으로 솔리리스 바이오시밀러를 출시했다. 삼성바이오에피스는 이번 허가로 미국 시장에서 총 8개 바이오시밀러 제품을 승인받았다. 미국에서도 자가면역질환 치료제, 항암제, 안과질환 치료제에 이어 혈액·신장질환 치료제 분야까지 치료 영역을 확대했다. 삼성바이오에피스 고한승 사장은 “미국에서도 희귀질환 치료제를 승인받아 글로벌 수준의 R&D 역량을 인정받았다”며 “에피스클리는 바이오시밀러의 사회적 가치를 극대화할 수 있는 제품으로서 세계 최대 의약품 시장인 미국에서도 그 가치를 실현하기 위해 지속 노력하겠다”고 전했다.
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- Reimb applied for new HIV drug 'Vocabria+Rekambys'
- by Eo, Yun-Ho Jul 24, 2024 05:50am
- Long-acting HIV treatment 'Vocabria+Rekambys' combination therapy aims to be listed for insurance reimbursement after receiving approval in South Korea two years ago. Industry sources said that GSK Korea and Janssen Korea have applied for reimbursement for the combination therapy of Vocabria (cabotegravir) and Rekambys (rilpivirine), which each company owns. GSK will be responsible for the overall reimbursement process. In February 2022, two drugs were approved by the Ministry of Food and Drug Safety (MFDS) as a combination therapy for the treatment of adult patients with HIV-1 infection who are virologically suppressed with no history of treatment failure and with no known or suspected drug tolerance to either cabotegravir or rilpivirine. In South Korea, Vocabria +Rekambys combination therapy was approved as injection therapy with intervals of monthly or bimonthly administration. The advantage of this combination therapy is its convenience. Previously, patients had to take a tablet formulation drug once daily for conventional HIV treatments. However, with the marketing approval of these two injectables, the treatment frequency has been reduced to monthly or bimonthly as an intramuscular injection, resulting in high patient satisfaction and reduced patient burden. These two drugs were initially developed as oral formulations and later developed as injectables. As a long-acting injection therapy, these drugs cannot cure HIV injection but target white blood cells, helping to lower and maintain AIDS virus replication. The combination therapy was approved in Europe in December 2020 after a clinical trial demonstrated its efficacy and safety in a patient group treated once every 4 weeks or once every 8 weeks. The most common adverse reactions observed in a group treated with Vocabria+Rekambys combination therapy include injection site reaction, headache, fever, nausea, fatigue, general malaise, and muscle aches. Consequently, it remains to be seen whether the government agency will approve the combination therapy of these two drugs for their advantage in convenience and whether the therapy will later become listed for reimbursement.
- Company
- Will 'Zejula' be reimbursed for HRD-positive ovarian cancer?
- by Eo, Yun-Ho Jul 23, 2024 05:48am
- Product photo of Takeda Pharmaceuticals Korea Whether the insurance reimbursement criteria for 'Zejula,' a PARP inhibitor, will include 'HRD-positive' is gaining attention. Sources said that Takeda Pharmaceuticals Korea is negotiating the price with the National Health Insurance Service (NHIS) for the Poly ADP-ribose Polymerase (PARP) inhibitor, Zejula, which is used to treat ovarian cancer. The drug price negotiation is intended to expand reimbursement for the drug. Zejula is currently reimbursed for use as maintenance therapy in patients with BRCA mutation ovarian cancer who have responded to first-line treatment with platinum-based chemotherapy. The company aims to add the condition of homologous recombination repair deficiency (HRD)-positive for Zejula during the negotiations. For the treatment of ovarian cancer, Zejula was the first PARP inhibitor to demonstrate efficacy by involving HRD-positive patients in clinical studies. However, the reimbursement was limited to BRCA mutation. Since then, the company has gathered significant data on Zejula in HRD-positive patients. In a phase 3 PRIMA follow-up study, predicted variables related to progression-free (PFS) in Zejula-treated patient group were analyzed. Based on the results, predicted variables for long-term PFS after the use of Zejula for first-line maintenance therapy were found to include having a BRCA mutation or HRD, FIGO staging, the primary site of tumor, and the number of non-target lesions with conditions. Patients treated with Zejula who have BRCA mutation or are HRD-positive are highly likely to maintain PFS for over two years. Patients who are tested positive for BRCA2 gene mutation or HRD had a higher odds ratio (OR) compared to other subgroup patients. In the PRIME study result, enrolling Asians (Chinese), a significant clinical treatment effect with Zejula for patients tested positive for BRCA mutation or HRD have been confirmed. In the study, Zejula-treated patients who tested positive for HRD had an ORR of 61.3%, higher than the 29.4% ORR in the placebo group. Jae Weon Kim, Professor in the Department of Obstetrics & Gynecology at Seoul National University Hospital, said, "For ovarian cancer patients who have remaining lesions, antitumor activation by PARP inhibitors is a crucial factor in delaying the progression of the disease and prolonging PFS in patients. The findings related to long-term benefits of Zejula, including improved prognosis, are encouraging."
- Company
- Opdivo approved as 1st-line Tx for urothelial cell carcinoma
- by Hwang, Byung-woo Jul 23, 2024 05:48am
- Pic of Opdivo Ono Pharma Korea and BMS Korea announced on the 22nd that Opdivo (nivolumab) has been additionally approved by the Ministry of Food and Drug Safety as a first-line treatment for urothelial cell carcinoma (UCC). The new indication is for the first-line treatment of unresectable or metastatic urothelial cell carcinoma in combination with cisplatin and gemcitabine. Patients with unresectable or metastatic urothelial cell carcinoma who have not received prior therapy are eligible to receive the combination treatment. The approval was based on the results of the Phase III CheckMate-901 study, which compared the use of Opdivo isplatin+gemcitabine combination followed by Opdivo monotherapy with the use of cisplatin+gemcitabine combination. In the study, the Opdivo combination arm demonstrated statistically significant and clinically meaningful improvements in the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by a blinded independent central review committee (BICR). The safety profile of Opdivo therapy in this study was consistent with the established safety profiles of the agents in previous trials and there was no new safety information. Opdivo was first approved in August 2017 as monotherapy for the treatment of patients with locally advanced or metastatic urothelial cell carcinoma whose disease has progressed after platinum-based chemotherapy. In February 2022, the drug was additionally approved as postoperative adjuvant therapy for patients with muscle-invasive bladder cancer (MIBC) at high risk of recurrence after radical resection.
