Already under pressure from its shareholders, AMAG faced a big decision from an FDA advisory committee on the future of its troubled premature-birth med Makena. Now, with the committee voting against it, Makena may not be long for the U.S. market.
Tuesday, an advisory committee voted 9-7 to recommend Makena's marketing withdrawal after the drug faced questions about its efficacy over placebo.
The seven committee members in dissent called for Makena to be put on accelerated approval and for a new confirmatory trial, arguing there were few treatments on the market for pregnant patients at risk of premature birth. AMAG said in a statement that it was disappointed with the recommendation.
"We are disappointed with the nearly split vote on this key question and we are committed to working with the FDA to identify feasible ways to generate additional efficacy data on Makena while retaining current access to the therapy for at-risk pregnant women,” AMAG Chief Medical Officer Julie Krop said.
