Makena Withdrawal Dilemma: Advisory Cmte. Split Offers No Clear Direction For US FDA
Nine of 16 advisory committee members favored withdrawal of AMAG’s preterm birth drug because substantial evidence of efficacy is lacking and clinical benefit has not been confirmed; seven panelists favored keeping the drug on the market but requiring a new trial.
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Accelerated Approval Reform Target? Makena Hearing Highlights Product Promotion During Withdrawal Period
Makena hearing and the product’s prolonged withdrawal process raises questions about whether FDA needs new authorities to curtail advertisement and ensure accurate patient and provider education after an accelerated approval drug’s confirmatory trial fails and/or during the period in which the agency is considering pulling the product from the market.
A Conspicuous Absence: Professional Societies ACOG, SMFM Missing From Makena Public Hearing
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.
US FDA Panel Says Covis’ Makena Should Be Withdrawn – And This Time It Wasn’t Close
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.