AMAG’s Makena: Did Accelerated Approval Kill The Confirmatory Trial?
Sponsor’s assertion that recruitment of high-risk, US patients was negatively impacted by the preterm birth drug’s availability under accelerated approval led some advisory committee members to opine that Makena came to market too soon; the experience could make the FDA more cautious about granting accelerated approval unless confirmatory studies are at an advanced stage.
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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.
Just three years ago, then-sponsor AMAG Pharmaceuticals said another trial of the preterm birth prevention drug in the US would be unethical and infeasible. Now, AMAG parent Covis is proposing to conduct a new study designed to address the shortcomings of the PROLONG trial.
The company seeks to keep Makena on the market with a narrower indication while it conducts a new randomized, controlled trial in the US, but the FDA’s drugs center says keeping the drug on the market would render a new trial infeasible and do a disservice to women at risk for preterm birth.