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Makena Hearing: Covis Seeks To Skip Question, Likely Negative Vote On Confirmatory Trial Results

Executive Summary

By proposing to stipulate that findings from the PROLONG study do not verify Makena’s clinical benefit on neonatal morbidity and mortality from complications of preterm birth, Covis could avoid what would likely be a highly negative vote on the first question posed to the advisory committee at the 17-19 October public hearing on withdrawal of the application.

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The two senior agency officials will render the decision together as co-signatories on whether Makena loses its accelerated approval or is allowed to stay on the market; that decision will not come before mid-January, and is likely to be weeks or months later, based on a timeline set out by hearing officer Celia Witten.

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With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior leadership.

CDER Opposes Covis’ Bid To Steer Focus Away From Makena's Failed Confirmatory Trial

The company offered to stipulate that findings from the PROLONG trial do not verify clinical benefit of the preterm birth prevention drug; the US FDA’s drugs center opposed a stipulation, saying failure of a confirmatory trial to verify clinical benefit is an independent ground for withdrawing accelerated approval and an advisory committee should vote on the question.

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