Makena, hydroxyprogesterone caproate, is an injection approved to stop preterm delivery before 37 weeks of gestation. It is intended for pregnant women who have had at least one spontaneous preterm birth, and is not advised for use with multiple fetuses, or other risk factors for pre-term birth.
One in every eight babies in the United States is born before 37 weeks — 1,500 every day, 13 of whom die from complications.
“Preterm birth is a significant public health issue in the United States,” said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. “This is the first drug approved by the FDA that is indicated to specifically reduce this risk.”
A health care provider injects Makena into a woman's hip weekly, beginning at 16 weeks, or no later than 21 weeks gestation.
The FDA approved Makena under its accelerated approval protocol, which requires a drug's manufacturer to continue to research the drug's efficacy and side effects. An international trial is now under way.
Hologic, a Bedford, Mass.-based manufacturing firm that concentrates on women's health, developed Makena, previously known as Gestiva. Hologic recently finalized the sale of the drug to KV Pharmaceuticals of St. Louis, Missouri.
The FDA okayed Makena's use based on a multicenter randomized double-blind trial that looked at 463 women ages 16 to 43 who had a history of preterm birth. Of the subjects treated with Makena, 37 percent delivered their babies before 37 weeks, compared with 55 percent of women in the control group.
The FDA previously approved hydroxyprogesterone caproate in 1956 under the name Delalutin. The drug was withdrawn from the market in 2001 "for reasons unrelated to safety concerns," according to the FDA.