FDA finalizes decision to end Lilly's GLP-1 shortage, analysts predict Novo will be next

Yahoo Finance12-20 04:57

The Food and Drug Administration has finalized its decision to call an end to the drug shortage of Eli Lilly's (LLY) blockbuster GLP-1 products, often referred to by their formula name, tirzepatide. ...

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Compounders, which invest millions in bulk buying of the key ingredient to make vials of the drugs, have now been put on notice.\"FDA’s decision today, reiterating that the tirzepatide shortage is resolved, reflects the tireless work of our manufacturing and quality colleagues to safely expand our manufacturing capacity to bring these medicines to people who need them,\" Lilly said in a statement to Yahoo Finance.\"Anyone marketing or selling unapproved tirzepatide knockoffs must stop,\" the company added.Boxes of Wegovy, Ozempic, and Mounjaro are sold in the Achat pharmacy in Mitte, Berlin. . \"The fact of the matter is that patients across the nation continue to","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"LU2237438978.USD":"Amundi Funds US Pioneer A2 (C) USD","BK4588":"碎股","LU2063271972.USD":"富兰克林创新领域基金","SG9999015945.SGD":"LionGlobal Disruptive Innovation Fund A SGD","LU2264538146.SGD":"Fullerton Lux Funds - Global Absolute Alpha A Acc SGD","ALUR":"ALLURION TECHNOLOGIES","IE00BK4W5L77.USD":"HSBC GLOBAL FUNDS ICAV US EQUITY INDEX \"HC\" (USD) ACC","IE00BZ1G4Q59.USD":"LEGG MASON CLEARBRIDGE US EQUITY SUSTAINABILITY LEADER \"A\"(USD) INC (A)","LU2361044949.HKD":"WELLINGTON US QUALITY GROWTH \"A\" (HKD) ACC","LLY":"礼来","LU0882574055.USD":"富达全球健康医疗A ACC","NVO":"诺和诺德","LU0079474960.USD":"联博美国增长基金A","LU0106261372.USD":"SCHRODER ISF US LARGE CAP \"A\" ACC","LU1814569148.SGD":"WELLINGTON GLOBAL QUALITY GROWTH \"D\" (SGDHDG) ACC","LU0203201768.USD":"AB SICAV I - ALL MARKET INCOME PORTFOLIO \"AX\" (USD) INC","LU0198837287.USD":"UBS (LUX) EQUITY SICAV - USA GROWTH \"P\" (USD) ACC","SGXZ57979304.SGD":"United Global Healthcare A Acc SGD-H","IE0002141913.USD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (USD) ACC","LU0708995401.HKD":"FRANKLIN U.S. OPPORTUNITIES \"A\" (HKD) ACC","IE00BJJMRZ35.SGD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"I2\" (SGDHDG) ACC","IE00BKVL7J92.USD":"Legg Mason ClearBridge - US Equity Sustainability Leaders A Acc USD","LU0354030438.USD":"富国美国大盘成长基金Cl A Acc","SG9999014906.USD":"大华全球优质成长基金Acc USD","LU0882574139.USD":"富达环球消费行业基金A ACC","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","BK4532":"文艺复兴科技持仓","BK4192":"特殊消费者服务","LU1974910355.USD":"Allianz Thematica Cl AMg DIS USD","SG9999001176.SGD":"UOB UNITED GLOBAL HEALTHCARE \"SGD\" (ACC)","BK4599":"减肥药","SG9999015952.SGD":"LIONGLOBAL DISRUPTIVE INNOVATION \"I\" (SGD) ACC","LU1267930730.SGD":"富兰克林美国机遇基金AS Acc SGD (CPF)","LU0238689110.USD":"贝莱德环球动力股票基金","LU0109391861.USD":"富兰克林美国机遇基金A Acc","SGXZ99366536.SGD":"United Global Innovation A Acc SGD-H","HIMS":"Hims & Hers Health Inc.","LU2106854487.HKD":"ALLIANZ THEMATICA \"AMG\" (HKD) INC","LU0256863902.USD":"ALLIANZ US EQUITY \"AT\" (USD) ACC","BK4533":"AQR资本管理(全球第二大对冲基金)","LU1551013342.USD":"Allianz Income and Growth Cl AMg2 DIS USD","LU1623119135.USD":"Natixis Mirova Global Sustainable Equity R-NPF/A USD","BK4007":"制药","LU0471298777.SGD":"Blackrock Nutrition A2 SGD-H","SGXZ51526630.SGD":"大华环球创新基金A Acc SGD","LU2237443622.USD":"Aberdeen Standard SICAV I - Global Dynamic Dividend A Acc USD","LU2023250504.SGD":"Allianz Thematica Cl AMg DIS H2-SGD","LU1280957306.USD":"THREADNEEDLE (LUX) US CONTRARIAN CORE EQUITIES \"AUP\" (USD) INC","GLP":"全球合伙","LU1804176565.USD":"EASTSPRING INV GLOBAL GROWTH EQUITY \"A\" (USD) ACC"},"translate_title":"FDA最终决定结束礼来GLP-1短缺，分析师预测Novo将是下一个","themeId":"2f2f105c7e0211c1363da017fa7bc417","isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"GLP":1,"HIMS":1,"NVO":1,"LLY":1,"ALUR":0.9},"content_text":"The Food and Drug Administration has finalized its decision to call an end to the drug shortage of Eli Lilly's (LLY) blockbuster GLP-1 products, often referred to by their formula name, tirzepatide.\nThe new decision comes after a lawsuit filed by compounders forced the FDA to announce it was reviewing its original decision from October. Compounders, which invest millions in bulk buying of the key ingredient to make vials of the drugs, have now been put on notice.\n\"FDA’s decision today, reiterating that the tirzepatide shortage is resolved, reflects the tireless work of our manufacturing and quality colleagues to safely expand our manufacturing capacity to bring these medicines to people who need them,\" Lilly said in a statement to Yahoo Finance.\n\"Anyone marketing or selling unapproved tirzepatide knockoffs must stop,\" the company added.\n\n\n\n  Boxes of Wegovy, Ozempic, and Mounjaro are sold in the Achat pharmacy in Mitte, Berlin. (Jens Kalaene/picture alliance via Getty Images)\n \n\n  picture alliance via Getty Images\n \n\nTirzepatide is the key ingredient in Lilly's blockbuster weight-loss drug Zepbound and diabetes drug Mounjaro. The FDA's decision starts a countdown clock of about 60 days, or until February, for copycat manufacturers to halt production.\nWhile Lilly and competitor Novo Nordisk struggled to meet unprecedented demand in the last few years, compounding pharmacies stepped up to fill the shortage gap, as allowed by the FDA. But once the shortage is over, patent enforcements go back into full swing. \nNovo Nordisk's (NVO) GLP-1 drugs, Ozempic for diabetes and Wegovy for weight loss, are also poised to be taken off the FDA's shortage list after the company notified the FDA of the drugs' availability in November. \nWeight-loss platforms such as Allurion (ALUR) will have to halt their planned rollout of tirzepatide copycats. The company's stock slid more than 13% on the news, trading at less than $0.30 per share. \nCopycats of Novo's semaglutide drugs are the more popular drugs available on telehealth platforms like Hims & Hers (HIMS), Ro, and Sesame — and could soon face a similar fate.\nThe news still crushed Hims stock Thursday afternoon. Shares traded down nearly 10% at $25.81 per share. \nPiper Sandler analysts said in a note that Hims should be fine \"for the time being.\" They noted, however, that the FDA's move does signal that it's \"not giving much leeway for the compounders.\"\nIt means these players will have to work more closely with pharma companies to gain access.\n\"We've proactively developed partnerships, including our recent collaboration with Eli Lilly, to ensure patients can access branded medications like Zepbound at more affordable price points,\" said Sesame president Michael Botta in a statement Thursday.\nThe trade group representing the copycat manufacturers said they disagree with the FDA's decision.\n\"The fact of the matter is that patients across the nation continue to experience difficulty filling prescriptions for branded tirzepatide products and that pharmacy distributors continue to list branded tirzepatide products as out-of-stock or available in only limited quantities,\" the Outsourcing Facilities Association said in a LinkedIn post.\nHims has also tried to appeal to the FDA that the shortages are not over, submitting a survey of members who reported experiencing shortages this year from September through November.\nEli Lilly and Allurion were not immediately available for comment. Hims declined to comment.\nAnjalee Khemlani is the senior health reporter at Yahoo Finance, covering all things pharma, insurance, care services, digital health, PBMs, and health policy and politics. That includes GLP-1s, of course. Follow Anjalee on social media platforms X (Twitter), LinkedIn Bluesky @AnjKhem.\nClick here for in-depth analysis of the latest health industry news and events impacting stock prices.","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":"4.29.3","shortVersion":"4.29.3","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/2492489076"}