FDA Approves Drug to Prevent Premature Births

Makena, a drug designed to prevent premature births in pregnant women who have previously gone into labor well before the end of term, has been approved by the Food and Drug Administration.

The drug, whose approval has been delayed for years by the FDA, is administered through a weekly shot to the hip of the mom-to-be. In testing of the drug, the proportion of woman who delivered spontaneously before 37 weeks of pregnancy was 37 percent in the group taking Makena, compared to 55 percent in the control group.

The principal side effects for the drug were pain and swelling around the site of the injection, as well as nausea and diarrhea.

“Preterm birth is a significant public health issue in the United States,” Dr. Sandra Kweder, deputy director of the FDA’s Office of New Drugs, said of Makena’s approval. “This is the first drug approved by the FDA that is indicated to specifically reduce this risk.”

Under the terms of the approval, the FDA ordered further testing to demonstrate a long-term clinical benefit of the drug, such as the absence of lingering developmental problems typically associated with premature births. The study will be completed in 2018.

The FDA, in its decision, also took into account testing that measured the progress of children, from the ages of 2½ through 5 years old, whose mothers had been treated with Makena. No developmental anomalies were uncovered.

Makena was developed by Hologic Inc. and is to be manufactured by Baxter Pharmaceutical Solutions. A tentative deal is in place for K-V Pharmaceutical Co. to market the drug.

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