FDA approves drug to reduce risk of premature births


For the first time, the Food and Drug Administration on Friday approved a drug to reduce the risk of premature delivery, although it required the manufacturer to conduct more studies to demonstrate the drug’s efficacy.

The agency gave the nod to a synthetic form of the hormone progesterone, which is normally produced during pregnancy, that can be injected into women who have already had a spontaneous preterm birth. The weekly injections, to be marketed under the name Makena, are for use only in women who are carrying a single fetus and who have no other risk factors for an early delivery.

The approval comes under the FDA’s accelerated approval program in which drugs are allowed on the market because they produce a result — in this case, preventing premature births — that is assumed to correlate with a clinical benefit as yet unproven by studies.


The drug’s manufacturer, K-V Pharmaceutical Co. of St. Louis, Mo., will be required to conduct further studies to demonstrate that the infants whose births are delayed by the drug will suffer fewer health and developmental problems as a result.

“It makes tremendous sense that prolonging pregnancy will result in long-term benefits,” said Dr. Alan Fleischman, medical director of the March of Dimes. Every week that babies aren’t born preterm or that their gestations are prolonged will almost certainly produce benefits, he said.

An estimated 500,000 babies are born prematurely in the United States each year, and those births are associated with a wide variety of health and developmental problems. According to the March of Dimes, about 10,000 of those preterm births could be prevented if all eligible women received the new drug, which is injected weekly beginning as early as 16 weeks after conception and no later than 21 weeks.

Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that doctors offer progesterone treatments to high-risk women. Because there have been no commercial products available, physicians have obtained the progesterone from so-called compounding pharmacies, which make it to order.

“What [the approval] does for both doctors and women is it makes a consistent and high-quality product available,” Fleischman said. “This makes sure women are getting the same drug used in trials.”

The drug will be available only from specialty pharmacies and will be express-mailed to physicians or patients, a company representative said. The representative would not comment on price, but Fleischman said “it is not going to be cheap. This is an orphan drug with a long period of development and a small number of eligible patients. But the drug company has committed itself to making sure every eligible woman has access to the drug.”


Zajac reported from Washington and Maugh reported from Los Angeles.