US regulator calls for withdrawal of approval for Makena

In what is not an unexpected decision, the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has proposed that Makena (hydroxyprogesterone caproate injection) be withdrawn from the market because the required post-market study failed to verify clinical benefit and it has been concluded that the available evidence does not show Makena is effective for its approved use.

Around a year ago, an FDA advisory panel voted 13 to 3 that clinical data submitted by the drug’s maker seeking full approval failed to demonstrate substantial evidence of effectiveness.

Originated by AMAG Pharmaceuticals (Nasdaq: AMGA) but now available as a generic, Makena received accelerated approval in 2011 to reduce the risk of preterm birth in women who previously had a spontaneous (unexplained) preterm birth, which is delivery of a baby before 37 weeks.