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End Of An Accelerated Approval Odyssey: Covis Agrees To Withdraw Makena But Seeks 21-Week ‘Wind-Down’

 
• By Sue Sutter

Covis says it respects advisory committee vote at October public hearing favoring withdrawal; proposal comes four years after failure of the PROLONG confirmatory trial to confirm clinical benefit in preventing preterm birth.

Brick wall
Covis acknowledges the end of the road for Makena, but seeks a 21-week reprieve. • Source: Shutterstock

Covis Pharma said it will “voluntarily withdraw” the preterm birth prevention drug Makena (hydroxyprogesterone caproate injection, also known as 17-OHPC or 17-P) from the US market, a decision that follows a multi-year fight with the FDA’s Center for Drug Evaluation and Research and an overwhelmingly negative advisory committee vote at an October 2022 public hearing.

However, the company requests the agency grant “an orderly wind-down” that would allow at least 21 weeks from the time of a withdrawal order for patients to complete their current course of

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