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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Makena Panel Vote Adversely Influenced By Framing Of Withdrawal Question, Covis Says
‘Ad hoc narrowing’ of the final voting question by hearing officer Celia Witten prevented adcomm members from voting on Covis’ proposal to restrict the preterm birth prevention drug's indication while further study was conducted, company says.
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.
Makena Randomized, Controlled Trial Proposal Shows Evolution In Covis’ Thinking
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.