After an extraordinary three-day hearing, an expert panel of advisers to the U.S. Food and Drug Administration voted on Wednesday to uphold an effort by the regulator to withdraw a controversial drug for preventing premature births.
The 14-to-1 vote came after the agency and Covis Pharma, the manufacturer of the drug, offered highly contrasting views of reams of clinical evidence — which they parsed in excruciating detail — in order to settle the fate of the treatment, known as Makena.
The FDA successfully persuaded the panel that the medication should be withdrawn because the results of a clinical trial, which was required when the agency approved Makena in 2011, failed to show the expected benefit. For its part, Covis maintained that a follow-up trial showed its drug did benefit a select subset of patients — including Black women — but struggled to convince the panel that the drug should remain available while a lengthy follow-up study is run to confirm its argument.
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