Makena

Treatment for Premature Labor

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

Adeza Announces August 29 FDA Advisory Committee Date to Review Gestiva to Prevent Preterm Births

SUNNYVALE, Calif., July 18, 2006 - Adeza today announced that its New Drug Application (NDA) for Gestiva will be reviewed by the Reproductive Health Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) on August 29, 2006. Gestiva, a long acting form of a naturally occurring progesterone, is the company's drug candidate to prevent preterm birth in women with a history of preterm delivery.

"The setting of an advisory committee meeting date marks an important next step in the Gestiva NDA review process," said Emory V. Anderson, president and chief executive officer. "A preterm birth occurs nearly every minute and imposes a $26 billion annual cost to the U.S. health care system. For the cases involving women with a prior history of preterm delivery, we believe Gestiva can help reduce costs by prolonging pregnancy and preventing preterm births."

In May 2006, Adeza announced the submission of its Gestiva NDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. Adeza was subsequently granted Priority Review for the Gestiva NDA and, pursuant to Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set a goal to complete its review or otherwise respond to Adeza on the Gestiva NDA by October 20, 2006. Priority Review is granted to product candidates that, if approved, would provide a significant improvement in the treatment, diagnosis or prevention of a disease.

The Gestiva NDA includes positive data from a 463-patient clinical study with 17 alpha-hydroxyprogesterone caproate (17P) in pregnant women with a history of preterm birth conducted by the National Institute of Child Health and Human Development, one of the institutes of the National Institutes of Health (NIH). 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 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 necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen, and mean number of days of respiratory therapy.

In 2003 the American College of Obstetricians and Gynecologists (ACOG) issued a recommendation for the use of progesterone in women with a history of prior preterm birth to help prevent preterm delivery, following publication of NIH study results in the June 2003 New England Journal of Medicine.

Posted: July 2006

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