Adeza says FDA to review preterm birth prevention drug Gestiva on Aug. 29

By E. Janene Geiss

Philadelphia, July 18 - Adeza said Tuesday that its New Drug Application for Gestiva will be reviewed by the Reproductive Health Drugs Advisory Committee to the Food and Drug Administration on Aug. 29.

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, according to a company news release.

A preterm birth occurs nearly every minute and adds $26 billion in annual costs to the U.S. health care system, officials said.

For the cases involving women with a prior history of preterm delivery, Adeza said it believes Gestiva can help reduce those costs by prolonging pregnancy and preventing preterm births.

In May, Adeza submitted its NDA for Gestiva. Adeza said it was subsequently granted priority review for the application 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 Oct. 20.

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 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.

Patients were enrolled at 16 to 21 weeks of gestation and randomly assigned to receive weekly injections of 17 alpha-hydroxyprogesterone caproate or a placebo until delivery or 37 weeks of gestation.

Treatment with 17 alpha-hydroxyprogesterone caproate 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 17 alpha-hydroxyprogesterone caproate had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen and mean number of days of respiratory therapy, officials said.

In 2003, the American College of Obstetricians and Gynecologists 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.

Adeza is a Sunnyvale, Calif., biopharmaceutical company focused on women's health.

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