FDA's RHDAC votes in favor of Adeza's Gestiva

USA-based Adeza, a manufacturer of women's health products, says that the Reproductive Health Drugs Advisory Committee of the Food and Drug Administration, has voted to support its New Drug Application for Gestiva (17-alpha hydroxyprogesterone caproate) for use in the prevention of pre-term birth. The committee found that the efficacy and safety data that the firm supplied support the drug's approval.

The NDA contains data from a National Institutes of Health study that enrolled 463 women with a history of pre-term birth, carried out at 19 trial centers. Enrollees were randomized to receive either an injection of Gestiva or placebo until delivery or 37 weeks gestation. The results showed that the drug brought about a 34% reduction in pre-term birth rate, as well as a 42% reduction in the rate of such births prior to 32 weeks gestation. The firm added that the study also demonstrated that infants born to treated mothers had significantly lower rates of necrotizing enterocolitis and intraventricular hemorrhage, and required a lower mean number of days of respiratory therapy.

Emory Anderson, Adeza's chairman, welcomed the committee's support for the product, adding that, "with approximately one pre-term birth every minute and a $26.0 billion annual cost to the US health care system, pre-term birth is a major public health issue." The FDA is expected to complete its review by October 20.