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news.The US Food and Drug Administration (FDA) has approved Makena (hydroxyprogesterone caproate) injection, to reduce the risk of preterm delivery before 37 weeks of pregnancy.
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Makena, sponsored by US-based Hologic, is indicated for pregnant women with a history of at least one spontaneous preterm birth.
The drug is not intended for women with multiple pregnancy, such as twin pregnancy, or other risk factors for preterm births.
The FDA approved Makena under the agency’s accelerated approval regulations, under which promising drugs are approved based on a surrogate endpoint benefit.
Under these regulations, the manufacturer must conduct additional studies following approval to demonstrate that the drug has clinical benefit.
FDA Center for Drug Evaluation and Research Office of New Drugs deputy director Sandra Kweder said that preterm birth is a significant public health issue in the US.
"This is the first drug approved by the FDA that is indicated to specifically reduce this risk," Kweder said.