October 5, 2020
The U.S. FDA’s Center for Drug Evaluation and Research (CDER) has proposed that Makena® (hydroxyprogesterone caproate injection – AMAG Pharmaceuticals) be withdrawn from the United States market. A post marketing study failed to verify Makena’s clinical benefit, and CDER has determined that available evidence does not show the product is effective for its approved use.
The post marketing study was a requirement of Makena’s 2011 accelerated FDA approval. Currently, the drug is indicated to reduce the risk of preterm birth in women who had previously had an unexplained preterm birth (delivery of a baby before 37 weeks).
The FDA and CDER have issued a notice of opportunity for a hearing (NOOH) to AMAG Pharmaceuticals and to application holders for approved Makena generics to provide them an opportunity to comment. Until the manufacturers decide to remove the products from the market, or the FDA Commissioner mandates their removal, Makena and its generic alternatives can continue to be sold in the U.S.
According to the FDA, healthcare professionals should speak to patients about the benefits, risks, and uncertainties associated with Makena’s use until a decision is made regarding the drug’s marketing status.
The FDA plans to meet with experts in obstetrics, neonatal care, and clinical trial design to discuss development of safe and effective and therapies to address preterm birth.
A full copy of the FDA’s announcement can be viewed on the agency’s website.