速递 | FDA最终决定结束礼来的替尔泊肽短缺问题，诺和诺德司美格鲁肽将成为下一个

GLP1减重宝典12-24 11:26

整理 | GLP1减重宝典内容团队12月20日，美国食品药品管理局最终决定结束礼来公司 (LLY) 重磅 GLP-1 产品替尔泊肽的药品短缺问题。礼来公司股价在周五收盘前盘前交易中上涨 9%。此前，复合药房提起的诉讼迫使 FDA 宣布审查其 10 月份的原始决定。复合药房投资数百万美元批量购买关键成分来制造山寨药品，现在他们已收到通知，停止其山寨行为。▍GLP-1短缺造成的山寨现状这一新闻引发了...

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月报告出现短缺的药品分销商。Allurion 表示，它将继续提供复方司美格鲁肽以及礼来和诺和诺德的品牌产品。","collect":0,"end_time":0,"defaultTopTitle":"qq.com","property":[],"viewcount":null,"language":"zh","relate_stocks":{"LU0882574139.USD":"富达环球消费行业基金A ACC","BK4516":"特朗普概念","SG9999017495.SGD":"UGDP UNITED GLOBAL QUALITY GROWTH \"B\" (SGD) ACC","IE00B4R5TH58.HKD":"JANUS HENDERSON GLOBAL LIFE SCIENCES \"A2\" (HKD) ACC","BK4599":"减肥药","SG9999013999.USD":"UOB UNITED GLOBAL HEALTHCARE FUND (USDHDG) INC","LU0943347566.SGD":"安联收益及增长平衡基金AM H2-SGD","LU0256863811.USD":"ALLIANZ US EQUITY \"A\" INC","LU0820561818.USD":"安联收益及增长平衡基金Cl AM DIS","NVO":"诺和诺德","LLY":"礼来","LU0823416689.USD":"BNP PARIBAS HEALTH CARE INNOVATORS \"C\" (USD) ACC","LU1989771016.USD":"东方汇理环球老龄化投资基金 A2 Acc","IE0004445239.USD":"JANUS HENDERSON US FORTY \"A2\" (USD) ACC","LU2491050154.USD":"WELLINGTON SUSTAINABLE OUTCOMES \"A\" (USD) ACC","LU2324357040.USD":"HSBC GIF GLOBAL EQUITY SUSTAINABLE HEALTHCARE \"AC\" (USD) 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今天的决定重申了替尔泊肽短缺问题已得到解决，这反映了我们制造和质量同事的不懈努力，他们安全地扩大了制造能力，将这些药物带给了需要它们的人。”该公司补充道：“任何营销或销售未经批准的替尔泊肽的非品牌复合药的人都必须停止。”替尔泊肽是礼来公司畅销减肥药 Zepbound 和糖尿病药物 Mounjaro 的关键成分。FDA 的决定启动了约 60 天的倒计时，即到 2 月份，复合版本制造商必须停止生产。▍下一个结束药品短缺的是诺和诺德礼来公司和竞争对手诺和诺德在过去几年里一直在努力满足前所未有的需求，而配药药房在FDA 允许的情况下加紧填补短缺空白。但一旦短缺结束，专利执法就会全面展开。诺和诺德的 GLP-1 药物Ozempic（用于治疗糖尿病）和 Wegovy（用于减肥）也即将从 FDA 的短缺名单中剔除，此前该公司于 11 月通知 FDA 这些药物的可获得性。▍复合药品制造商受到影响Allurion (ALUR) 等减肥平台将不得不停止计划推出替尔泊肽非品牌复合药。受此消息影响，该公司股价下跌逾 13%。诺和诺德司美格鲁肽药物的复合药是 Hims & Hers (HIMS)、Ro 和 Sesame 等远程医疗平台上最受欢迎的药物。周四下午，礼来的消息仍重创 Hims 股价。股价下跌近 10%，周五盘前，Hims 股价进一步下跌 4%。Piper Sandler 分析师在一份报告中表示，FDA 的举动确实表明它“没有给复合药物生产商太多回旋余地”。这意味着这些参与者必须与制药公司更紧密地合作才能获得药物。“我们积极发展合作伙伴关系，包括最近与礼来公司的合作，以确保患者能够以更实惠的价格获得Zepbound 等品牌药物，”Sesame 总裁Michael Botta 在周四的一份声明中表示。代表山寨制造商的贸易集团表示，他们不同意 FDA 的决定。“事实上，全国各地的患者仍然难以获得品牌替尔泊肽产品的处方，药店分销商继续将品牌替尔泊肽产品列为缺货或数量有限，”外包设施协会表示。Hims 还试图向 FDA 呼吁，短缺问题尚未结束，提交了一份调查，调查对象是今年 9 月至 11 月报告出现短缺的药品分销商。Allurion 表示，它将继续提供复方司美格鲁肽以及礼来和诺和诺德的品牌产品。*本文仅供医疗卫生专业人士参考▼相关链接▼▼关注我们▼加入专家库与我们深度讨论▂▂▂▂▂“GLP-1俱乐部”覆盖数百位专业人士，构建了围绕GLP-1产业链上下游、覆盖多个板块的专家库，成为了业内顶尖专业人士获取行业真知灼见的首要选择。加入专家库请添加下方“运营负责人”微信，并提供名片和必要的个人信息。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"productRelease","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; 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