AMAG reports on FDA advisory committee meeting to consider status of Makena which has been approved to reduce preterm birth.

AMAG Pharmaceuticals, Inc. announced the FDA Bone, Reproductive and Urologic Drugs Advisory Committee met to better understand and interpret the PROLONG (Progestin�s Role in Optimizing Neonatal Gestation) confirmatory clinical trial for Makena (hydroxyprogesterone caproate injection), a treatment approved to reduce preterm birth in pregnant women who have had a prior spontaneous preterm birth.

While the committee discussed multiple questions, in a mixed vote on the key question, nine advisory committee members voted to recommend that the FDA pursue withdrawal of approval for Makena and seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial. Among the clinicians on the advisory committee, five of the six who practice obstetrics voted to keep Makena on the market and generate more data.

Comment: Makena was originally approved by the FDA under accelerated approval following positive data from one study of 463 pregnant women. The approval was conditional on Amag carrying out a confirmatory trial to affirm Makena's effectiveness in reducing the rate of preterm delivery, as well as assess whether treatment lowered neonatal mortality or morbidity. Results from that study,completed in March 2019, were decisively negative, showing no difference between Makena and placebo on either measure.