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Adeza given priority review by FDA for Gestiva to prevent premature births
New York, June 5 - Adeza said the Food and Drug Administration has granted priority review status to its New Drug Application for Gestiva.
The status sets a six-month goal for review by the FDA and is intended for product candidates that have the potential to provide a significant improvement in the treatment, diagnosis or prevention of a disease.
The deadline for review or response for Gestiva is Oct. 20.
Gestiva, a long-acting form of a naturally occurring progesterone, is Adeza's drug candidate for prevention of preterm birth in women with a history of preterm delivery.
Adeza's application 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.
The institute 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. 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.
Adeza, located in Sunnyvale, Calif., designs, manufactures and markets products for women's health.
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