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US FDA Still Hasn’t Decided Who Will Be Final Arbiter On Approval Status For Covis’ Makena

Executive Summary

With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior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

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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.

Covis, CDER Lay Out Arguments Ahead Of Makena’s Accelerated Approval Withdrawal Hearing

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.

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A workshop broadcast from White Oak was a shift from the fully virtual meetings held since the height of the COVID-19 pandemic and may be a step toward once again staging public events there.

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