Results from a 1,700-patient international study in 2019 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for infants.
“I do think that our patients deserve an answer and they deserve that well-designed clinical trial and I think that taking the drug off the market is going to allow that,” said Dr. Mary Munn of the University of South Alabama.
FDA's approval was conditioned on a larger follow-up study to confirm whether Makena resulted in healthier outcomes for babies. Luxembourg-based Covis Pharma argued this week that Makena benefits women at highest risk of early deliveries, including Black Americans, and proposed narrowing its approval to that group while it conducted another study to confirm effectiveness. The company's presentations included outside experts who said removing Makena would worsen racial disparities in prenatal care.
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FDA Panel Wants Removal of Unproven Pregnancy Drug Meant to Prevent Premature BirthsResults from a 1,700-patient international study in 2019 showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for infants.
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