FDA approves drug to prevent premature births

February 11, 2011

FDA has approved hydroxyprogesterone caproate injection (Makena [formerly known as Gestiva], Hologic and KV Pharmaceutical Co.), the first drug to help prevent premature delivery before 37 weeks in women who have had at least 1 previous preterm birth.

FDA has approved hydroxyprogesterone caproate injection (Makena [formerly known as Gestiva], Hologic and KV Pharmaceutical Co.), commonly referred to as “17P,” the first drug to help prevent premature delivery before 37 weeks in women who have had at least 1 previous preterm birth.

The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth.

FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women. The approved indications include threatened miscarriage. The original manufacturer requested the withdrawal of Delalutin from the market in 2000 for reasons unrelated to safety.

Prior to FDA’s approval of Makena, healthcare providers ordered prescriptions of 17P from compounding pharmacies; however, many eligible patients faced logistical and financial barriers to access.

“Progesterone is really the one weapon we have right now to prolong gestation in women with a prior history of preterm birth,” Edmund F. Funai, MD, professor, Department of Obstetrics, Gynecology and Reproductive Sciences, Yale University School of Medicine, told Formulary. “Unfortunately, there have been significant issues in obtaining access to it, due to various regulations about medication compounding. This is a great leap forward, and should help smaller and more rural practices incorporate its use into practice.”

Mitzi Wasik, PharmD, BCPS, regional director, clinical pharmacy, Coventry Healthcare, Downers Grove, Ill., shared a similar viewpoint. “The American College of Obstetrics and Gynecology has recommended weekly 17P injections for high-risk pregnancies since 2003,” Dr Wasik said. “Until now, women had to obtain the medication from specialized compounding pharmacies and faced logistical and financial barriers of access. The introduction of this new product will allow more women who meet criteria as high risk for preterm delivery to receive preventative treatment.”

FDA reviewed data on the safety and effectiveness of Makena in a multicenter randomized double-blind clinical trial. The study included 463 women aged 16 to 43 years who were pregnant with a single fetus and had a history of a prior spontaneous preterm birth. Among women treated with Makena, 37% delivered early (before 37 weeks) as compared with 55% of women in the control group.A separate study evaluated the development of children born to mothers enrolled in the controlled trial. In this study, children aged 2.5 years to 5 years reached similar developmental targets, regardless of the mother’s treatment. The confirmatory study that is ongoing will be followed by a similar infant follow-up study, to be completed about 2018.

A healthcare provider would administer the once-weekly Makena injection into the hip. Treatment should begin at 16 weeks and no later than 21 weeks of pregnancy and continue until 37 weeks gestation.

A published study by the March of Dimes, the National Institutes for Health, and the Centers for Disease Control and Prevention, using data from 2002, estimated that if all women eligible for the progesterone injections received them, nearly 10,000 spontaneous premature births might be prevented each year.