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Earlier this month, Switzerland-based Covis Pharma announced it would voluntarily pull Makena, an unproven drug intended to prevent premature births, from the U.S. market.
The March 7 announcement came roughly four years after Makena failed to show a benefit in helping mothers carry pregnancies to term.
Since then, the Food and Drug Administration tried to get the drug off the market, but Covis kept asking for time to do more research. The injectable drug has become an example of the challenges the Food and Drug Administration faces in forcing drug manufacturers to take their drugs off the market.
About 10% of U.S. births come too early, before 37 weeks, raising the risk of serious health problems and even death in infants. The problem occurs at higher rates among Black women, a USA TODAY analysis of maternal mortality rates found.
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What is Makena, and what is it designed to do?
Makena is a synthetic version of the hormone progesterone, which is needed to maintain a pregnancy. The treatment involves weekly injections starting after 16 weeks of pregnancy.
It’s the only drug the FDA had approved to reduce the risk of premature birth.
Why is Makena being taken off the market?
The FDA granted Makena accelerated approval in 2011 based on a small study in women with a history of early deliveries. The expedited approval was conditioned on a larger follow-up study to confirm whether the drug resulted in healthier outcomes for babies.
In 2019, results from that 1,700-patient international study showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for infants.
In 2020, the FDA proposed removing Makena from the market. Covis, in turn, requested a rare hearing to make its case for keeping the drug on the market. In October, the FDA’s advisory panel, made up of gynecologists, obstetricians and other fetal medicine experts, voted to withdraw Makena, citing recent study results that showed it did not prevent health problems in newborns of mothers who took the drug.
Despite those results, reproductive specialists — including the American College of Obstetricians and Gynecologists — argued for keeping the decade-old drug available while more research was done. A spokesperson for the group said it will await the FDA’s final decision on the drug.
Premature birth rates in the US:The rate of babies born premature saw a ‘concerning’ increase in 2021, report finds
Is Covis Pharma’s Makena effective?:FDA panel recommends pulling Makena, citing ineffectiveness of controversial preterm birth drug
What’s next for the premature birth drug?
The timing of the drug’s removal is unclear. FDA Commissioner Robert Califf is expected to soon decide on the drug’s fate, in consultation with the agency’s top scientist.
Covis said in its release that FDA regulators rejected its proposal to wind down the drug’s use over several months. That extended off-ramp would give women who are still receiving the drug time to finish their course of treatment, the company said.
But the FDA made clear it would continue its internal process to force the drug’s removal on its own terms, according to the company.
“While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntarily withdraw the product and work with the FDA to effectuate an orderly wind-down,” Covis Chief Information Officer Raghav Chari said in a statement.
The company added that it “remains ready to work cooperatively with the agency,” to remove the drug, despite disagreement on the timeframe.
The Associated Press contributed to this report.
nshuda@dispatch.com
@NathanielShuda
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