Effectiveness Or Bust: Without Benefit, No Case For Keeping Makena On The Market, CDER Says
FDA Center for Drug Evaluation and Research officials say accelerated approval of Covis’ preterm birth prevention drug should be withdrawn because substantial evidence of effectiveness no longer exists – separate from any concerns about study feasibility, off-label use or compounding.
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In a memo to Commissioner Califf and Chief Scientist Bumpus, Celia Witten focuses the final Makena decisionmakers on the key factors she believes should be used to determine the drug’s market status.
The American College of Obstetricians and Gynecologists and Society for Maternal-Fetal Medicine did not testify at the public hearing on CDER’s proposal to withdraw the preterm birth prevention drug, even though the groups’ clinical guidelines still recommend use of Makena and its active ingredient.
Covis declines to commit to conducting another randomized, placebo-controlled trial if the preterm birth prevention drug is withdrawn, saying currently available data from physician and patient surveys suggest a new study may not be feasible if approval is pulled.