Makena Follows Avastin’s Path With US FDA Hearing On Accelerated Approval Withdrawal
Executive Summary
Chief scientist Denise Hinton will decide the fate of Covis’ preterm birth prevention drug because acting commissioner Janet Woodcock has recused herself; CBER deputy director Celia Witten is tapped to serve as presiding officer at the hearing, which will be only the second of its kind under accelerated approval regulations.
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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.
US FDA Still Hasn’t Decided Who Will Be Final Arbiter On Approval Status For Covis’ Makena
With two weeks to go before hearing on whether the preterm birth prevention drug can stay on the market or be withdrawn, the lack of clarity on who will make the ultimate decision may stem from the lengthy duration of the dispute and multiple transitions within FDA’s senior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.
Makena Accelerated Approval Withdrawal Hearing Should Be In-Person, Covis Tells US FDA
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