Makena: New Randomized Trial May Only Happen If Drug Stays On The US Market
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declines to commit to conducting another randomized, placebo-controlled trial if the preterm birth prevention drug is withdrawn, saying currently available data from physician and patient surveys suggest a new study may not be feasible if approval is pulled.
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Ahead of the final withdrawal decision, FDA terminated internal separation of functions so that the Office of the Commissioner and CDER could coordinate next steps; Makena’s NDA approval has been withdrawn, but the product’s website lives on, albeit with a pop-up window explaining the regulatory action.
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.
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.