In an unexpected turn of events, the Food and Drug Administration will hold a hearing on whether Covis Pharma should voluntarily withdraw its controversial treatment for preventing premature births after a key study found the medicine is ineffective.
The move comes nearly two years after an FDA advisory panel recommended that the medication, known as Makena, should be withdrawn after the trial failed to verify a clinical benefit. The 9-to-7 vote called into question the future of a medication that has been the standard of care across the U.S. since it was approved a decade ago.
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