智通财经APP获悉，葛兰素史克(GSK.US)宣布，其一款治疗重度哮喘的新药已获美国监管批准，这一 进展有望为该药物成为重磅产品铺平道路。 葛兰素史克在周三发布的一份声明中表示，美国食品药品监督管理局(FDA)已批准新药 Exdensur(depemokimab)作为12岁及以上重症哮喘患者的附加维持疗法。 作为首款治疗呼吸系统疾病的超长效生物制剂，Exdensur的给药频率仅为每年两次。临床试验数据显 示，该药物可使重度哮喘急性发作风险降低54%，同时还能缓解慢性鼻窦炎患者的鼻塞症状，并缩小鼻 息肉体积。 本月早些时候，这款药物刚获得欧洲药品管理局的上市许可，英国药品监管机构也已为其亮绿灯。葛兰 素史克透露，目前该药物在中国与日本的上市申请正处于审评阶段。 据葛兰素史克估计，目前美国约有200万人患有重症哮喘，其中半数患者仍面临频繁的病情加重和住院 风险。 Exdensur被视为葛兰素史克未来增长的关键部分。公司计划在2026年至2027年间，逐步拓展该药物在多 种适应症上的应用。葛兰素史克预计，Exdensur的年销售额有望高达30亿英镑(约合40亿美元)。 ...

Core Insights - GSK plc announced FDA approval for Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in patients aged 12 and older [1][9]. Clinical Trial Results - The FDA approval is based on the SWIFT-1 and SWIFT-2 phase III trials, where depemokimab showed a 58% and 48% reduction in annualized asthma exacerbations compared to placebo over 52 weeks [2]. - A pooled analysis indicated a 72% reduction in clinically significant exacerbations requiring hospitalization or emergency department visits for depemokimab compared to placebo [3]. Treatment Benefits - Depemokimab offers sustained protection from exacerbations with only two doses per year, potentially redefining patient care for severe asthma [4]. - The treatment is well-tolerated, with side effects similar to those of placebo [3]. Market Context - Approximately 2 million Americans suffer from severe asthma, with half experiencing frequent exacerbations that lead to increased healthcare costs [5]. - Currently, only 20% of eligible patients in the US receive biologics, indicating a significant unmet need in the market [5]. Future Prospects - Depemokimab has received a positive opinion from the CHMP in Europe, with an approval decision expected in Q1 2026, and is under review in other regions including China and Japan [7]. - GSK is expanding its pipeline for depemokimab to include other diseases with type 2 inflammation, such as chronic rhinosinusitis and chronic obstructive pulmonary disease (COPD) [18].

葛兰素史克公司周二表示，美国卫生监管机构已批准该公司用于治疗重症哮喘的附加药物，这为患者选 择一种用药频率较低的治疗方案进入市场铺平了道路。 责任编辑：王永生 葛兰素史克公司周二表示，美国卫生监管机构已批准该公司用于治疗重症哮喘的附加药物，这为患者选 择一种用药频率较低的治疗方案进入市场铺平了道路。 责任编辑：王永生 ...

The U.S. Food and Drug Administration has approved GSK's add-on drug to treat asthma and a chronic inflammatory sinus condition, the drugmaker said on Tuesday, paving the way for a less frequently dosed treatment option for patients to enter the market. ...

UK's health regulator on Monday approved GSK's twice-yearly drug for use as an add-on treatment for asthma in patients aged 12 and older, as well as for a chronic inflammatory sinus condition in adult... ...

Key Takeaways CHMP backed Nucala as an add-on therapy for COPD, with a European decision expected in early 2026.A monthly injectable Nucala targets IL-5 to help uncontrolled COPD patients reduce hospital visits.Depemokimab won CHMP support after studies showed twice-yearly efficacy in asthma and CRSwNP.GSK plc (GSK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has given a positive opinion recommending the approval of Nucala as an add-on main ...

Over the past two months, that is how much time has passed since my article "GSK's Hidden Growth Engines Beyond HIV and Oncology," GSK's shares ( GSK ) ( GLAXF ) have risen by 12.5%.With over two decades of dedicated experience in investment, Allka Research has been a guiding force for individuals seeking lucrative opportunities. Its conservative approach sets it apart, consistently unearthing undervalued assets within the realms of ETFs, commodities, technology, and pharmaceutical companies.Allka Research' ...

Key Takeaways GSK secures FDA approval for Blujepa to treat uncomplicated urogenital gonorrhea.The approval is based on EAGLE-1 data showing non-inferiority to standard combination therapy.Study results also highlighted Blujepa's favorable safety and tolerability profile.GSK plc (GSK) announced that the FDA has approved its supplemental new drug application (sNDA) seeking approval for its oral antibiotic Blujepa (gepotidacin) for treating uncomplicated urogenital gonorrhea (uGC) in adult and pediatric patie ...

Regulatory Approval - Europe's drug regulator backed GSK's drug [1] - This is the first such recommendation globally for this medicine [1] Pharmaceutical Industry Impact - The drug is pegged to become a blockbuster [1] - The drug is for treating severe asthma or a common nasal condition [1]

Core Viewpoint - GSK's RSV vaccine, Arexvy, has received backing from a panel of the European Medicines Agency for use in all adults over the age of 18, indicating a significant step towards broader vaccine availability [1] Group 1 - The European Medicines Agency's panel supports the use of Arexvy for adults aged 18 and older, which may enhance GSK's market position in the respiratory vaccine sector [1] - This endorsement could lead to increased sales and revenue opportunities for GSK as the demand for respiratory vaccines rises [1]