FDA One Step Closer To Makena Withdrawal After Hearing Officer Echoes Advisory Panel’s Advice
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.
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Fourteen of 15 advisory committee members said the preterm birth prevention drug should come off the market while a new study is conducted; panelists cited concerns about allowing continued marketing when efficacy has not been demonstrated, and they rejected Covis’ assertion that it would be harder to recruit a new study if Makena were pulled.
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declines to commit to conducting another randomized, placebo-controlled trial if the preterm birth prevention drug is withdrawn, saying currently available data from physician and patient surveys suggest a new study may not be feasible if approval is pulled.
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for Drug Evaluation and Research officials say accelerated approval of Covis’ preterm birth prevention drug should be withdrawn because substantial evidence of effectiveness no longer exists – separate from any concerns about study feasibility, off-label use or compounding.