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Makena

Generic name: hydroxyprogesterone caproate
Treatment for: Premature Labor

Update: Makena (hydroxyprogesterone caproate) Now FDA Approved - February 3, 2011

FDA Advisory Committee Recommends Approval of Adeza’s NDA for Gestiva to Prevent Preterm Birth

SUNNYVALE, Calif., August 29, 2006 - Adeza today announced that the Reproductive Health Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) recommended by a majority vote that the data presented by Adeza in its New Drug Application (NDA) for Gestiva support efficacy in preventing preterm birth prior to 35 weeks and that overall safety data is adequate and sufficiently reassuring to support marketing approval in women with a history of preterm delivery. The Advisory Committee also recommended the collection of post marketing clinical data. Although Advisory Committee recommendations are not binding, typically FDA final determinations are consistent with their recommendations. Pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has a goal to complete its review or otherwise respond to the Gestiva NDA by October 20, 2006.

"We are pleased by the Advisory Committee's support for this important therapeutic for the prevention of preterm birth in women with a history of preterm delivery," said Emory V. Anderson, president and chief executive officer. "With approximately one preterm birth every minute and a $26 billion annual cost to the U.S. health care system, preterm birth is a major public health issue. Treating women with a history of preterm birth with Gestiva could considerably reduce preterm birth and the associated costs for this high risk group."

Gestiva is a long-acting form of a naturally occurring progesterone. The use of this form of progesterone is recommended by the American College of Obstetricians and Gynecologists (ACOG) in the treatment of women for recurrent preterm birth. If Gestiva receives FDA approval, Adeza will have the only commercially available, NIH-studied, ACOG-recommended and FDA-approved therapeutic for the prevention of recurrent preterm birth.

In May 2006, Adeza announced the submission of its NDA to the FDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, which allows for FDA approval of new or improved formulations of previously approved products. In June 2006, Adeza's NDA for Gestiva was granted Priority Review status. Adeza's NDA submission for Gestiva includes data from a clinical study conducted by the National Institute of Child Health and Human Development, one of the institutes of the National Institutes of Health (NIH). The NIH studied a long-acting form of a naturally occurring progesterone, 17 alpha-hydroxyprogesterone caproate (17P), in a multi-center, double-blind, placebo-controlled trial that enrolled 463 women with a prior history of preterm birth in 19 clinical trial centers. Patients were enrolled at 16 to 21 weeks of gestation and randomly assigned to receive weekly injections of 17P or placebo until delivery or 37 weeks of gestation. Treatment with 17P, as reported in the June, 2003 New England Journal of Medicine, resulted in an overall reduction in the preterm birth rate of 34% and a reduction of 42% in the rate of preterm births prior to 32 weeks. In addition, infants born to women treated with 17P had significantly lower rates of serious complications such as necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen, and mean number of days of respiratory therapy.

Posted: August 2006

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