An expert panel convened by the US Food and Drug Administration voted 14-1 on Wednesday to recommend withdrawing a preterm pregnancy treatment from the market, saying it does not work.
During the sometimes contentious three days of hearings, the drugmaker Covis Pharma, backed by some clinicians and patient groups, had argued there is evidence to suggest the drug, called Makena, might work in a narrower population that includes Black women at high risk of giving birth too soon.
But FDA experts and others said the data does not support such a view. In closing arguments, Peter Stein, director of the Office of New Drugs at the FDA’s Center for Drug Evaluation and Research, agreed on the urgent need for a drug to reduce the incidence of preterm birth — a leading cause of infant mortality in the United States. But he said the data indicates that Makena is not that drug.
Stein said, “Hope is a reason to keep looking for options that are effective,” he said. “Hope is not a reason to take a drug that is not shown to be effective, or keep it on the market.”
Read full story
Source: The Washington Post, 19 October 2022