The Food and Drug Administration questioned whether a proposed drug designed to prevent preterm labor was effective at stopping the earliest labors that are most linked to death and serious health problems.
The proposed drug, Gestiva, by Adeza Biomedical Corp. of Sunnyvale, Calif., is a long-acting form of a naturally occurring progesterone and is designed to prevent preterm labor.
There is currently no approved drug for preterm labor on the U.S. market, although some drugs are used off-label to prevent uterine contractions.
Gestiva is set to be considered today by an outside panel of medical experts that advises the FDA on reproductive drug approvals.
The FDA, which posted its review of the drug on its Web site yesterday, said that while Gestiva appears to reduce births before the 37th week, considered the cutoff point for a newborn to be considered premature, study results didn't show a big difference at stopping labor before either week 35 or week 32 of pregnancy. A full-term pregnancy is considered 40 weeks.
The FDA also expressed concern about an increase in the miscarriage rate among some women receiving Gestiva compared to those receiving a placebo, "and a suggestion of an increase in stillbirth rate." The FDA said it would ask the panel for advice on whether more follow-up studies are needed.
The drug is designed to be injected weekly, starting between 16 and 20 weeks of pregnancy through week 37, or birth.
Adeza said it expects the FDA to make a decision on whether to approve Gestiva by about Oct. 20.
In documents also posted on the FDA's Web site, Adeza said, "The benefits of postponing pregnancy by even one week are considerable." Both the company and the FDA noted that the number of preterm births in the U.S. has been on the rise.
Shares of Adeza were down 45 cents, or 2.9%, to $15.30 in 4 p.m. composite trading on the Nasdaq Stock Market.
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