On Tuesday, October 29, the Food and Drug Administration’s Bone, Reproductive, and Urologic Drugs Advisory Committee panel met to discuss the approval status of Makena (hydroxyprogesterone caproate injection) for reducing the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The Committee reviewed results from the PROLONG study: Progestin’s Role in Optimizing Neonatal Gestation, a postapproval trial comparing the efficacy of 17p intramuscular injection weekly with placebo. ACOG recently released a Practice Advisory with information about the findings of this study.
At the meeting, nine members of the committee voted to recommend that FDA pursue withdrawal of Makena; seven members voted to recommend that Makena remain on the market pending a new trial, and no members voted to recommend that Makena remain on the market without any additional study.
Pending any additional action from the FDA, Makena’s approval remains in place and the drug remains on the market. ACOG will monitor any additional actions or communications from the FDA and will inform ACOG members about any developments that may impact them or their patients.
Additional information about the Prediction and Prevention of Preterm Birth can be found in Practice Bulletin 130.