FDA“三思“将礼来(LLY.US)减肥神药移除短缺名单,Hims & Hers Health(HIMS.US)应声上涨10%

智通财经网
15 Oct 2024

智通财经APP获悉,在美国食品药品监督管理局(FDA)决定将礼来公司(LLY.US)的替西帕肽(Tirzepatide)从药品短缺清单中移除后,一起针对此次除名举措的诉讼引发了Hims & Hers Health(HIMS.US)周一交易上涨,收涨9.68%。这场诉讼导致FDA现正对除名重新考虑。替西帕肽以Mounjaro和Zepbound的名称出售,分别用于治疗2型糖尿病和减肥症。

10月7日,代表复方药房的行业组织外包设施协会(Outsourcing Facilities Association)向德克萨斯州的一家联邦法院提起诉讼,声称FDA在剥夺消费者获得替西肽的权利方面做出了“鲁莽和武断的决定”。该组织声称替西帕肽仍然供应不足,并要求FDA撤销其决定。

据悉,如果品牌药物被FDA认定为短缺,规则允许混合药房生产仍有专利保护的该药物。此前,礼来公司已解决替西帕肽的短缺问题并通知FDA,该监管机构现已确定该类药物供应问题得到解决,因而将药物移出了名单。

这意味着,根据FDA的指导方针,复合药房将不再被允许生产和销售这些药物的仿制品。对于无法负担原研药高昂费用的患者来说,可能会失去获取这些减肥药物的途径。

10月11日,FDA表示,在他们的审查完成之前,不会对生产自身版本的替西帕肽的复方药店和设施采取监管行动。

这一决定对Hims & Hers Health等远程医疗公司来说是个好消息,因为它们可以继续提供复合版本的减肥药物。Hims & Hers Health的股价因此在周一交易中上涨了约10%。

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