FDA Withdraws Lone Premature Birth Drug Makena Over Lack of Proven Benefits
FDA Withdraws Lone Premature Birth Drug Makena Over Lack of Proven Benefits
美国食品药品管理局因缺乏经证实的益处而撤回了唯一的早产药物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宣布了撤回对私人控股的批准的最终决定-Covis Pharma Makena（己酸羟孕酮注射液），一种通过加速批准途径获得批准的药物，可降低早产风险。
- 该决定由美国食品和药物管理局局长兼首席科学家联合发布。
- 从今天起，Makena及其仿制药不再获得批准，也不能合法分发。
- 美国食品和药物管理局于2011年通过加速批准途径批准了Makena，其依据是确定发起人已在中间临床终点上表现出药物作用，这种效果很有可能预测临床益处。
- 该机构的批准要求赞助商进行上市后的确认性研究。
- 确认性研究并未证实临床益处，美国食品药品管理局药物评估与研究中心（CDER）提议在2020年撤回该药物的批准。
- 发起人要求举行听证会，听证会于2022年10月举行。
- 10月，美国食品药品管理局的产科、生殖和泌尿科药物咨询委员会投票决定，Makena不应继续投放市场，因为一项大型研究未能证明其有效。
- 《华尔街日报》写道，Makena可能有副作用，包括血块、抑郁和过敏反应。
- 科维斯此前曾表示，该药物具有良好的安全记录，不良事件很少见，但美国食品药品管理局表示，一些证据表明，可能存在尚不为人知的长期风险。