FDA Withdraws Lone Premature Birth Drug Makena Over Lack of Proven Benefits
FDA Withdraws Lone Premature Birth Drug Makena Over Lack of Proven Benefits
美國食品藥品管理局因缺乏經證實的益處而撤回了唯一的早產藥物Makena
- Today, the FDA announced the final decision to withdraw approval of Privately held-Covis Pharma's Makena (hydroxyprogesterone caproate injection), a drug approved under the accelerated approval pathway to reduce the risk of preterm birth.
- The decision was issued jointly by the FDA Commissioner and Chief Scientist.
- Effective today, Makena and its generics are no longer approved and cannot lawfully be distributed.
- The FDA approved Makena under the accelerated approval pathway in 2011 based on a determination that the sponsor had demonstrated a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit.
- The agency's approval required the sponsor to conduct a post-marketing confirmatory study.
- The confirmatory study did not verify clinical benefit, and the FDA's Center for Drug Evaluation and Research (CDER) proposed withdrawing the drug's approval in 2020.
- The sponsor requested a hearing, which was held in October 2022.
- In October, the FDA's Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted that Makena should not remain on the market after a large study failed to show that it was effective.
- Wall Street Journal writes that Makena has possible side effects, including blood clots, depression, and allergic reactions.
- Covis said previously that the drug has a strong safety record and that adverse events are rare, but the FDA has said some evidence suggests there may be long-term risks that aren't yet well understood.
- 今天，FDA宣佈了撤回對私人控股的批准的最終決定-Covis Pharma Makena（己酸羥孕酮注射液），一種通過加速批准途徑獲得批准的藥物，可降低早產風險。
- 該決定由美國食品和藥物管理局局長兼首席科學家聯合發佈。
- 從今天起，Makena及其仿製藥不再獲得批准，也不能合法分發。
- 美國食品和藥物管理局於2011年通過加速批准途徑批准了Makena，其依據是確定發起人已在中間臨牀終點上表現出藥物作用，這種效果很有可能預測臨牀益處。
- 該機構的批准要求贊助商進行上市後的確認性研究。
- 確認性研究並未證實臨牀益處，美國食品藥品管理局藥物評估與研究中心（CDER）提議在2020年撤回該藥物的批准。
- 發起人要求舉行聽證會，聽證會於2022年10月舉行。
- 10月，美國食品藥品管理局的產科、生殖和泌尿科藥物諮詢委員會投票決定，Makena不應繼續投放市場，因爲一項大型研究未能證明其有效。
- 《華爾街日報》寫道，Makena可能有副作用，包括血塊、抑鬱和過敏反應。
- 科維斯此前曾表示，該藥物具有良好的安全記錄，不良事件很少見，但美國食品藥品管理局表示，一些證據表明，可能存在尚不爲人知的長期風險。
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