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FDA Approves Makena™, the First and Only Treatment to Reduce the Risk of Preterm Birth in Women With a Singleton Pregnancy Who Have a History of Singleton Spontaneous Preterm Birth
Date:2/4/2011

f all preterm births in the United States.  In 2005, preterm birth was estimated to cost the nation more than $26 billion.  According to a study published in Obstetrics and Gynecology, although the causes of spontaneous preterm birth are often unknown, a leading risk factor for preterm birth is a history of prior preterm birth.   Makena is approved to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth, which is a subset of the overall population of women at risk for preterm birth.  

"Preterm birth is a national healthcare crisis. The approval of this new treatment is a breakthrough in our fight against preterm birth," said Alan R. Fleischman, M.D., Medical Director, March of Dimes.  "Although the United States has made great progress in caring for premature babies, there is no greater advance than allowing a baby to mature in a mother's womb."

Makena is a prescription hormone (progestin) medicine used in women who are pregnant and who have delivered a baby too early (preterm) in the past.  Makena is used in these women to help lower the risk of having a preterm baby again. The approval of Makena was based on a study of 463 women who had experienced a previous singleton spontaneous preterm birth.   The study, sponsored by the National Institutes of Health, showed that compared to controls, treatment with Makena reduced the proportion of women who delivered preterm at less than 37 weeks.  After adjusting for time in the study, 7.5 percent of Makena-treated subjects delivered prior to 25 weeks compared to 4.7 percent of control subjects.  Makena is administered by a healthcare provider via a weekly intramuscular injection (every 7 days) beginning between 16 and 20 weeks of pregnancy and continuing until 37 completed weeks or until delivery, whichever comes first.In partnership with the Society for Maternal-Fetal Medicine, the Ame
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