Makena should be withdrawn from the market because a postmarketing study did not show clinical benefit, according to a statement released today from the Center for Drug Evaluation and Research at the Food and Drug Administration.
The drug, hydroxyprogesterone caproate injection, was approved in 2011 to reduce the risk of preterm birth in women who with previous spontaneous preterm birth. The FDA approved the medication under an accelerated pathway that required another trial to confirm clinical benefit.
The required postmarketing study “not only failed to demonstrate Makena’s benefit to the neonate, but also failed to substantiate any effect of Makena on the surrogate endpoint of gestational age at delivery that was the basis of the initial approval,” Patrizia Cavazzoni, MD, acting director of the CDER, wrote in a letter to AMAG Pharma USA, which markets Makena. The letter also was sent to other companies developing products that use the drug.
Beyond the lack of efficacy, risks associated with the drug include thromboembolic disorders, allergic reactions, decreased glucose tolerance, and fluid retention. “The risk of exposing treated pregnant women to these harms, in addition to false hopes, costs, and additional healthcare utilization outweighs Makena’s unproven benefit,” Dr. Cavazzoni said.
The letter notifies companies about the opportunity for a hearing on the proposed withdrawal of marketing approval. Makena and its generic equivalents will remain on the market until the manufacturers remove the drugs or the FDA commissioner mandates their removal, the CDER said.
The FDA commissioner ultimately will decide whether to withdraw approval of the drug. An FDA panel previously voted to withdraw the drug from the market in October 2019, and the drug has remained in limbo since.
Health care professionals should discuss “Makena’s benefits, risks, and uncertainties with their patients to decide whether to use Makena while a final decision is being made about the drug’s marketing status,” the CDER announcement said.
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