FDA advisory panel recommends approval of experimental preterm labor prevention drug

An FDA advisory committee on Tuesday voted 13-8 that clinical trial data regarding Adeza's experimental preterm labor prevention drug Gestiva was adequate to approve the drug, Dow Jones reports (Corbett Dooren, Dow Jones, 8/29).

The panel also voted unanimously to recommend that further studies on Gestiva be conducted after FDA approval (Wall Street Journal, 8/30).

If Adeza's application is accepted, Gestiva would be the only FDA-approved drug to prevent premature deliveries for women with histories of early labor.

According to FDA documents reviewing Gestiva posted Monday on the agency's Web site, the results of a clinical trial do not show "statistically persuasive" evidence that the drug -- injected weekly from between 16 and 20 weeks' gestation to either the 36th week or birth -- reduces the number of births before either 32 or 35 weeks' gestation.

However, Gestiva seems to reduce births before 37 weeks' gestation, which are considered premature.

Although most cases of death and health problems among premature infants occur among infants born before 32 weeks' gestation, FDA's review says Gestiva's apparent effectiveness in preventing births before 37 weeks' gestation is "noteworthy" because most premature infants are born after 32 weeks.

The review also says the drug appears to increase the risk of miscarriage and might increase the stillbirth rate.

FDA has granted Gestiva priority-review status, and Adeza in a release said it expects the agency to decide on its application by Oct. 20 (Kaiser Daily Women's Health Policy Report, 8/29).

FDA usually follows its advisory panels' advice, but it is not required to do so, according to Dow Jones (Dow Jones, 8/29).

Panel Discussion

Although the committee of experts from outside the agency recommended approval of Gestiva, almost all panelists expressed apprehensions about the drug, Daniel Shames, deputy director of FDA's office that oversees reproductive drugs, said (Bridges, AP/San Diego Union Tribune, 8/29).

Panel members said postmarket studies of the drug should focus on potential links between the drug's use and miscarriages or stillbirths and should follow for several years the health of infants born to women who take the drug.

Future studies should be conducted by NIH or other researchers independent of Adeza, according to Ezra Davidson, an associate dean at the Charles E. Drew University of Medicine and Science in Los Angeles.

Representatives from the company told the panel that women taking Gestiva experienced pregnancies that lasted an average of one week longer than those of women not taking the drug.

This assertion was supported by FDA (Dow Jones, 8/29).

About 12% of U.S. infants born in 2002 were premature, an increase of 29% from 20 years ago, according to FDA.

The agency has said unapproved progesterone compounds are currently "being used widely" (Kaiser Daily Women's Health Policy Report, 8/29).

March of Dimes Medical Director Nancy Green said approval of Gestiva would allow progesterone to be covered by Medicaid and to be generally available in pharmacies (Heavey, Reuters, 8/29).