FDA grants Gestiva NDA priority status

California, USA-based medical technology firm Adeza, a specialist developer of products for the women's health market, says that the Food and Drug Administration has granted the firm's New Drug Application for Gestiva (17 alpha hyroxyprogesterone caproate) priority review status. The product, which is designed to prevent preterm birth in women with a history of early delivery, is a long-acting formulation of progesterone that reduced the rate of premature births in recent trials, when compared with placebo.

The company also said that the American College of Obstetrics and Gynecologists has recommended the use of this form of progesterone in the treatment of recurrent preterm births, adding that, if fully approved by the FDA, Gestiva would be the only commercially-available progesterone product that has been assessed by the US National Institute of Child Health and Human Development.

Analysts at the USA-based March of Dimes group estimate that $18.0 billion in additional costs were associated with premature births and low-birth weight infants in 2003, and that preterm birth, specifically, is responsible for nearly 85% of pregnancy-related complications and deaths in the USA each year.