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# FDA Wants Makena Withdrawn While New Trial Conducted
- URL: https://www.fdaweb.com/fda-wants-makena-withdrawn-while-new-trial-conducted/
- Published: 2022-10-07T12:00:00.000Z
- Updated: 2026-09-14T18:02:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152922

An FDA briefing document released in advance of a 10/17-19 advisory committee meeting to discuss whether the accelerated approval of Covis’ Makena (hydroxyprogesterone caproate injection, 250 mg/mL, once weekly) should be withdrawn argues strongly that the drug is not effective and has known risks. It was approved in 2011 for reducing the risk of pre-term birth in women with a singleton pregnancy.

In the [briefing document](http://file///C:/Users/dave/Downloads/FDA-2020-N-2029-0274%5Fattachment%5F1-1.pdf?ref=fdaweb.com), FDA says Makena has not been shown to improve neonatal outcomes from premature birth, and that its confirmatory trial “failed to show that Makena has any benefit to newborns. Data from this trial, taken together with other evidence, also fail to show that Makena reduces the risk of recurrent preterm birth,” it says in arguing that the drug should be withdrawn from the market.

FDA notes that Covis has proposed to conduct a prospective, randomized, double-blind, placebo-controlled trial, but it would take at least 10 years to conduct it. It says such a trial is not feasible while Makena is still on the market. Patients are “less likely to enroll in trial for a drug approved to treat a serious condition and risk receiving a placebo when they can simply receive the drug by not enrolling in such a trial,” the agency says.

The advisory committee will discuss whether a confirmatory trial verified the clinical benefit of Makena and whether available evidence demonstrates that Makena is effective for its approved indication. They will also discuss whether FDA should allow Makena to remain on the market while an appropriate confirmatory study is designed and conducted.