FDA and Covis to face off over preterm birth drug Makena

Privately-held Covis Pharma knows what it is up against from the US Food and Drug Administration (FDA) as the regulator attempts to have the company’s preterm birth (PTB) drug Makena (hydroxyprogesterone caproate) withdrawn from the market.

Makena received accelerated approval in 2011 for the reduction in the risk of recurrent preterm birth (PTB) in pregnant women with a history of a singleton spontaneous PTB.

In seeking this accelerated approval, Covis relied on data from the Maternal Fetal Medicine Unit Network Trial 002, in which - compared to placebo - Makena reduced the proportion of women delivering prior to 37 weeks gestation, a surrogate endpoint reasonably likely to predict clinical benefit to neonates.