Adeza submits NDA for Gestiva to prevent preterm births

By Lisa Kerner

Erie, Pa., May 4 - Adeza said it has filed a New Drug Application with the Food and Drug Administration for Gestiva, the company's drug candidate to prevent preterm birth (delivery before 37 weeks gestation) in women with a history of preterm delivery.

The company has requested priority review and orphan drug designation as part of the Gestiva NDA.

Gestiva is a long-acting, naturally occurring form of progesterone, according to a news release.

Adeza's submission for Gestiva includes data from a clinical study conducted by the National Institute of Child Health and Human Development of 463 women. Preterm birth rate decreased 37% among women treated with naturally occurring progesterone.

In addition, infants born to the progesterone-treated women had lower rates of necrotizing enterocolitis, intraventricular hemorrhage, use of supplemental oxygen, and mean number of days of respiratory therapy.

Adeza said that if approved, Gestiva would be the only commercially available, NIH-studied, ACOG-recommended and FDA-approved therapeutic for the prevention of recurrent preterm birth.

Preterm births have accounted for up to 85% of all pregnancy-related complications and deaths in the United States, according to the New England Journal of Medicine.

Adeza, located in Sunnyvale, Calif., designs, manufactures and markets products for women's health.

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