New Drug Lowers Preterm Birth Risk
FDA Approves Makena to Reduce Risk in Women With History of Premature Delivery
Feb. 8, 2011 -- The FDA has approved an injectable drug called Makena to reduce the risk of preterm delivery before 37 weeks in pregnant women who have had at least one premature birth.
Makena, or hydroxyprogesterone caproate, was approved under the federal agency’s accelerated approval regulations, which allows drugs that show promise to get to the marketplace quickly.
FDA says in a news release that Makena is not meant to be used in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth.
Makena will be manufactured by Baxter Pharmaceuticals for K-V Pharmaceutical/Ther-Rx Corporation. The company states in an email to WebMD that it is working diligently to bring Makena to the market as soon as possible.
FDA Accelerated Approval
Under the FDA’s accelerated approval rules, K-V Pharmaceutical must conduct additional research to demonstrate its efficacy and show it has a clinical benefit.
According to the FDA, an international trial is under way aimed at learning if there also is improvement in the outcome of babies born to women given Makena, such as reducing the number of babies who do not survive or who suffer serious health problems shortly after birth.
“Preterm birth is a significant public health issue in the United States,” says Sandra Kweder, MD, deputy director of the FDA’s Office of New Drugs. “This is the first drug approved by the FDA that is indicated to specifically reduce this risk.”
Makena: Weekly Injections
The FDA says a health care provider would give Makena once weekly by injection into the hip and that treatment should begin between 16-21 weeks of pregnancy.
The FDA says it reviewed data on the safety and efficacy of the drug in a randomized, double-blind clinical trial that included 463 women aged 16 to 43 who were pregnant with a single fetus and who had a history of a prior spontaneous preterm birth.
It says that among women treated with Makena, 37% delivered before 37 weeks, compared to 55% of women not taking the drug.
Another study evaluated the development of children born to mothers enrolled in the controlled trial. In that study, children aged 2 1/2 to 5 reached similar developmental targets regardless of the mother’s treatment.