FDA Withdraws Lone Premature Birth Drug Makena Over Lack of Proven Benefits

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.