FDA AdCom votes for withdrawal of Covis' Makena

The US Food and Drug Administration’s (FDA) Obstetrics, Reproduction and Urologic Advisory Committee yesterday voted to recommend that the FDA pursue withdrawal of approval of privately-held Swiss drugmaker Covis Pharma’s Makena (hydroxyprogesterone caproate injection), the only FDA-approved treatment to reduce the risk of preterm birth in pregnant women who have had a prior spontaneous preterm birth.

After an unusually long three-day session, the AdCom voted 14-1 backing the stance of FDA briefing papers ahead of the meeting that Covis Pharma's preterm birth (PTB) drug Makena should be taken off the market because it failed a Phase III confirmatory study.

Not supported by post-marketing study