WASHINGTON — The maker of the only U.S. drug intended to prevent premature births is making a last-ditch effort this week to keep its medication on the market, even as health regulators insist that it doesn’t work.
About 10% of U.S. births come too early — before 37 weeks, raising the risk of serious health problems and even death in infants. Complicating the Makena debate is support from the leading U.S. obstetrics group to keep the decade-old drug available while more research is done. “Based on the evidence shown today, Makena is not shown to be effective,” said FDA’s drug chief, Dr. Patrizia Cavazzoni, in opening remarks Monday. “Its benefit and risk profile is unfavorable and it should be withdrawn from the market.”, which allows drugs like Makena to launch based on promising early results while additional, usually larger, studies are conducted.
In recent years, the FDA’s cancer division has begun prodding companies to stop selling their drugs for uses granted under these so-called The FDA approved Makena in 2011 based on a small study suggesting it reduced rates of premature birth in women with a history of early deliveries. Makena consists of a synthetic version of the hormone progesterone, which helps the uterus grow and maintain a pregnancy. Women can start the shots after 16 weeks of pregnancy.
In briefing documents released this month, the FDA said leaving Makena on the market “incurs false hopes, the risks associated with treatment, and other burdens” like excess medical spending. According to a recent
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Company pushes back against FDA efforts to remove pregnancy drugA Food and Drug Administration meeting that opened Monday comes more than two years after the agency declared the drug Makena ineffective and called for its removal.
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