FDA panel advises taking preterm birth drug off the market

An FDA advisory panel voted 14-1 on Wednesday to recommend that the agency withdraw its approval of the drug Makena, saying the treatment does not appear to reduce the risk of preterm birth.

That proposal was challenged by drug maker Covis Pharma, which is based in Luxembourg and has U.S. offices in King of Prussia. The, given that there were few effective treatments for preventing premature birth. In a recent report, an oversight office at the U.S. Department of Health and Human Services found flaws with the accelerated process through which Makena and certain other drugs are approved.

Among the panel members who voted no in Wednesday’s hearing was biostatistician Susan S. Ellenberg, a professor emerita at the University of Pennsylvania’s Perelman School of Medicine.

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