FDA Accepts GSK's Filing for Expanded Use of Nucala in COPD

Zacks2024-12-10

GSK plc GSK announced that the FDA has accepted its regulatory filing, seeking the approval of a new indication for Nucala (mepolizumab) in chronic obstructive pulmonary disease (COPD) treatment for ...

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Please note that Nucala is already approved in the United States for four IL-5-mediated conditions — severe eosinophilic asthma , chronic rhinosinusitis with nasal polyps in adults, eosinophilic granulomatosis with polyangiitis in adults and hypereosinophilic syndrome in patients aged 12+. Currently, the drug is not approved for COPD worldwide.In the past three months, shares of GSK have plunged 21.6% compared with the industry’s 6.2% decline.The new drug application for Blenrep, in combination with J&J’s Velcade  plus dexamethasone , is supported by interim results of the phase III head-to-head DREAMM-7stu","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU0306806265.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" ACC","SG9999002224.SGD":"Allianz Global High Payout SGD","LU0058720904.USD":"联博国际健康护理基金A","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","LU1894683264.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) ACC","IE00B3T34201.USD":"BNY MELLON GLOBAL EQUITY INCOME \"B\" (USD) INC","BK4548":"巴美列捷福持仓","LU1066051498.USD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM2\" (USD) INC","IE00B7SZLL34.SGD":"Legg Mason ClearBridge - Value A Acc SGD-H","LU1066053197.SGD":"HSBC GIF GLOBAL EQUITY VOLATILITY FOCUSED \"AM3\" (SGDHDG) INC","ALNY":"阿尔尼拉姆制药公司","LU0868494617.USD":"UBS (LUX) EQUITY SICAV - US TOTAL YIELD SUSTAINABLE \"P\" (USD) ACC","GILD":"吉利德科学","LU0122379950.USD":"贝莱德世界健康科学A2","LU0225284248.USD":"SCHRODER ISF GLOBAL EQUITY YIELD \"A\" ACC","BK4592":"伊斯兰概念","BK4532":"文艺复兴科技持仓","BK4599":"减肥药","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","BK4534":"瑞士信贷持仓","SG9999001176.USD":"United Global Healthcare Acc USD","LU1585245621.USD":"EASTSPRING INV GLOBAL LOW VOLATILITY EQUITY FUND \"A\" (USD) ACC B","BK4585":"ETF&股票定投概念","LU1894683348.USD":"AMUNDI FUNDS US EQUITY RESEARCH VALUE \"A2\" (USD) INC","PFE":"辉瑞","GSK":"葛兰素史克","LU1829250122.USD":"高盛欧洲核心股票组合Acc","IE00BLSP4239.USD":"Legg Mason ClearBridge - Tactical Dividend Income A Mdis USD Plus","BK4533":"AQR资本管理(全球第二大对冲基金)","BK4007":"制药","BK4566":"资本集团","SG9999003800.SGD":"Nikko AM Global Dividend Equity Acc SGD-H","LU0306807586.USD":"SCHRODER ISF GLOBAL DIVIDEND MAXIMISER \"A\" (USD) INC QF","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","LU0234570918.USD":"高盛全球核心股票组合Acc Close","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","LU1839511570.USD":"WELLS FARGO GLOBAL FACTOR ENHANCED EQUITY \"I\" (USD) ACC","LU0170899867.USD":"EASTSPRING INVESTMENTS WORLD VALUE EQUITY  \"A\" (USD) ACC","LU1883839398.USD":"AMUNDI FUNDS INCOME OPPORTUNITIES \"A2\" (USD) ACC","LU0456855351.SGD":"JPMorgan Funds - Global Equity A (acc) SGD","BK4568":"美国抗疫概念","LU1057294990.SGD":"Blackrock World Healthscience A2 SGD-H","LU0320765992.SGD":"FTIF - Franklin Biotechnology Discovery A Acc SGD","GSK.UK":"葛兰素史克","IE00BBT3K403.USD":"LEGG MASON CLEARBRIDGE TACTICAL DIVIDEND INCOME \"A(USD) ACC","LU0109394709.USD":"富兰克林生物科技新领域基金A (acc)","LU0234572021.USD":"高盛美国核心股票组合Acc","IE00BSNM7G36.USD":"NEUBERGER BERMAN SYSTEMATIC GLOBAL SUSTAINABLE VALUE \"A\" (USD) ACC","SG9999002232.USD":"Allianz Global High Payout USD","BK4581":"高盛持仓"},"translate_title":"FDA接受GSK扩大Nucala在COPD中使用的申请","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"ALNY":1,"GILD":1,"GSK":1,"PFE":0.9,"GSK.UK":0.6},"content_text":"GSK plc GSK announced that the FDA has accepted its regulatory filing, seeking the approval of a new indication for Nucala (mepolizumab) in chronic obstructive pulmonary disease (COPD) treatment for review. A decision from the regulatory body is expected on May 7, 2025.\nGSK’s Nucala is a monoclonal antibody with a novel mechanism of action that targets IL-5, a key messenger protein (cytokine) in type 2 inflammation. Please note that Nucala is already approved in the United States for four IL-5-mediated conditions — severe eosinophilic asthma (aged 6+), chronic rhinosinusitis with nasal polyps in adults, eosinophilic granulomatosis with polyangiitis in adults and hypereosinophilic syndrome in patients aged 12+. Currently, the drug is not approved for COPD worldwide.\nIn the past three months, shares of GSK have plunged 21.6% compared with the industry’s 6.2% decline.\nImage Source: Zacks Investment Research\nMore on the FDA Acceptance of GSK’s Nucala Filing for COPD\nGSK’s regulatory filing seeking the approval of Nucala as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype was supported by positive data from its phase III MATINEE study. The late-stage study evaluated the efficacy and safety of the drug in 804 patients with COPD who have evidence of type 2 inflammation detected by blood eosinophil count, a biomarker.\nThe MATINEE study achieved its primary endpoint, demonstrating that adding Nucala to inhaled maintenance therapy significantly and meaningfully reduced the annualized rate of moderate to severe exacerbations compared to placebo in patients treated for 52 to 104 weeks. Subject to approval, Nucala can become the first approved biologic with monthly dosing for patients with COPD.\nCOPD is a progressive and heterogeneous inflammatory lung disease that encompasses chronic bronchitis and emphysema. It ranks as the third leading cause of death, accounting for more than three million fatalities each year. In the United States, it impacts more than 14 million people, leading to approximately 500,000 hospitalizations and up to 1.3 million emergency department visits yearly, costing the U.S. healthcare system around $7 billion.\nFiling for Multiple Myeloma Combo Therapy Accepted in China\nIn a separate press release, GSK announced that the regulatory body in China has accepted its regulatory filing for Blenrep (belantamab mafodotin) combo therapy as a treatment for relapsed or refractory multiple myeloma (RRMM), under the Priority Review pathway. The combo therapy enjoys the Breakthrough Therapy designation in China for the RRMM indication, which is intended to expedite the development process of the novel therapy.\nThe new drug application for Blenrep, in combination with J&J’s Velcade (bortezomib) plus dexamethasone (BVd), is supported by interim results of the phase III head-to-head DREAMM-7 study. The late-stage study achieved the primary endpoint demonstrating a statistically significant and clinically meaningful improvement in progression-free survival for BVd compared to standard-of-care (SoC) triplet combo in RRMM patients. Per data from a subsequent interim analysis, the DREAMM-7 study also met its key secondary endpoint of overall survival, showing that treatment with the Blenrep combo significantly reduced the risk of death compared to SoC treatment.\nRegulatory applications seeking approval for the combination use of Blenrep in RRMM are also currently under review in six other major countries, including the United States, the EU and the U.K.\n\nGSK PLC Sponsored ADR Price and Consensus\n\nGSK PLC Sponsored ADR price-consensus-chart | GSK PLC Sponsored ADR Quote\n\nGSK’s Zacks Rank & Stocks to Consider\nGSK currently carries a Zacks Rank #3 (Hold).\nSome better-ranked pharma stocks are Alnylam Pharmaceuticals ALNY, Pfizer PFE and Gilead Sciences GILD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.\nOver the past 60 days, Alnylam Pharmaceuticals’ loss estimates have narrowed from 42 cents to 39 cents per share for 2024, while that for 2025 has narrowed from 49 cents to 13 cents. ALNY shares neither gained nor lost in the past three months.\nAlnylam Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 65.67%.\nIn the past 60 days, Pfizer’s earnings estimates have risen from $2.62 to $2.91 per share for 2024, while that for 2025 has increased from $2.84 to $2.91. PFE shares have lost 13.5% in the past three months.\nPfizer’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 74.50%.\nIn the past 60 days, Gilead Sciences’ earnings estimates have risen from $3.79 to $4.32 per share for 2024, while that for 2025 has increased from $7.24 to $7.38. GILD shares have risen 13.1% in the past three months.\nGilead Sciences’ earnings beat estimates in three of the trailing four quarters and missed the same in one, delivering an average surprise of 15.46%.\nWant the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report\nGSK PLC Sponsored ADR (GSK) : Free Stock Analysis Report\nAlnylam Pharmaceuticals, Inc. (ALNY) : Free Stock Analysis Report\nPfizer Inc. (PFE) : Free Stock Analysis Report\nGilead Sciences, Inc. (GILD) : Free Stock Analysis Report\nTo read this article on Zacks.com click here.\nZacks Investment Research","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.30.0","shortVersion":"4.30.0","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2490774709"}