Makena Follows Avastin’s Path With US FDA Hearing On Accelerated Approval Withdrawal

23 Aug 2021

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.

Footsteps in sand — Covis is following Genentech's footsteps on a route that will take the Makena sponsor to a public hearing under the accelerated approval regulations. • Source: Alamy

US Food and Drug Administration chief scientist Denise Hinton will decide the fate of the preterm birth prevention drug Makena now that the agency has granted sponsor Covis Pharma’s request for a public hearing in its fight to retain accelerated approval.

In an 18 August letter, Hinton concluded a hearing was appropriate on the Center for Drug Evaluation and Research’s...