Under its accelerated approval program, the FDA announced Friday that it has given the go-ahead to K-V Pharmaceutical Co.’s new drug Makena, a synthetic form of progesterone used to reduce the risk of premature delivery.
Though the drug manufacturer must still complete post-market surveillance studies demonstrating the drug’s safety and efficacy, Makena will be available as a weekly injection to women carrying a single fetus who have already had a spontaneous preterm birth and who possess no other risk factors for an early delivery. The drug would begin to be administered between their 16th and 21st week of gestation and continue until term.
The approval was based on a study of 463 women between the ages of 16 and 43 with a history of a previous spontaneous preterm birth. Results demonstrated that 37 percent of women treated with Makena injections gave birth before 37 weeks of pregnancy compared to 55 percent of women in the control group.
“Though a difference of 18 percent may not sound like a lot initially, when you consider that approximately 500,000 infants are born prematurely in the U.S. each year, this improvement would actually be a major benefit,” says ACSH's Dr. Gilbert Ross. Indeed, the March of Dimes estimates that nearly 10,000 preterm births could be prevented if all eligible women receive the new drug, which according to the manufacturer, will only be available from specialty pharmacies.