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FDA committee votes to pull US approval for AMAG's preterm birth drug Makena

Published on 31/10/19 at 10:08am

An FDA committee has passed a contentious vote recommending by a slim majority for the withdrawal of existing approval of AMAG Pharmaceuticals’ Makena (hydroxyprogesterone caproate injection) in the US market.

The US regulator’s Bone, Reproductive and Urologic Advisory Committee voted nine in favour, seven against the proposition, with the latter voting to keep the drug on the market but under the condition that a confirmatory trial is held. Makena is currently approved to reduce the incidence of preterm birth in pregnant women who have previously experienced spontaneous preterm birth.

The vote is not binding and will not necessarily lead to any action, but the FDA traditionally tends to follow the recommendations of its committees.

“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,” remarked Julie Krop, Chief Medical Officer at AMAG. “Preterm birth is an urgent public health crisis and the implications of leaving pregnant women and providers without access to therapy that is manufactured in a safe and regulated way is profoundly troubling. For more than a decade, healthcare providers have relied on hydroxyprogesterone caproate to reduce preterm delivery in high-risk patients, which aligns with recently updated treatment recommendations of the American College of Obstetricians and Gynecologists, as well as the Society for Maternal-Fetal Medicine.”

Makena was originally approved by the FDA in 2011, with Orphan Drug exclusivity until 3 February 2018.

Matt Fellows

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