Gestiva – the pre-term birth drug probed by FDA

According to federal documents released on Monday, a drug that aims to prevent preterm birth doesn’t seem to be effective in delaying the earliest preterm births, the main cause of death and serious health problems.

Sunnyvale-based Adeza's (NASDAQ:ADZA) drug, Gestiva, is a long-acting form of naturally occurring progesterone and is awaiting federal approval.

The Food and Drug Administration documents reveal that the results of a single clinical trial were not “statistically persuasive” in signifying that Gestiva reduced birth before either 32 or 35 weeks of gestation. But the study proposes that the drug does reduce births before 37th week. Weekly injections of Gestiva results in “substantial reduction” in preterm births among women most at risk, according to Adeza Biomedical Corp. in FDA filings.

According to FDA, even this effect could be “noteworthy”, as several preterm births occur after 32 weeks.

Usually, there are no serious and long-term developmental problems in babies born after 32 weeks of gestation. Whereas, those born before this period though account for only 2% of births, are the majority of cases of death and other problems associated with premature birth.

According to FDA, there is a 29% rise over the last 20 years in premature birth rate in the U.S. that rose to 12% in 2002. Fertility treatments and late pregnancy are the reasons for this rise, the FDA said.

The documents were released by the FDA prior to the meeting on Tuesday where an external panel of experts would recommend whether the drug application filed by the company should be approved by the FDA or not. The drug may cause an increase in miscarriage and stillbirth rate, said the FDA. Will the drug need further research, will be one of the questions posed to the panel. As per FDA rules, the pharmaceutical companies usually, should submit the results of at least 2 clinical trials.

If approved, then Gestiva would be the only FDA-approved drug to avoid preterm birth. This drug is already being manufactured and sold by a few specialty pharmacies without federal approval.

In 1956, the drug was approved by FDA to prevent spontaneous abortion. However, in 2000, the approval was withdrawn by the FDA after its manufacturer stopped selling it.

The drug is proposed to be used in women who already have a history of at least one preterm birth. It is meant to be given as weekly injections from the 16th to 20th week of pregnancy till the 36th week, or birth.