- 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.
