After years of disputes with the US Federal Drug Administration (FDA), the maker of a drug that is supposed to prevent premature birth but apparently doesn’t, is voluntarily withdrawing it from the market .
Manufacturer Covis Pharma opted to pull the drug, Makena, from shelves after the FDA indicated it was taking steps to remove it from the market anyway. Plans to do so have been delayed for more than 12 years as Covis tried to prove the drug effective but couldn’t.
“While we maintain Makena’s favorable risk-benefit profile, including its efficacy in women at increased risk of preterm birth, we seek to voluntarily withdraw the product and work with the FDA to effect an orderly liquidation,” said Covis’ chief innovation officer. raghavchari said in a statement.
“We appreciate the attention the agency has directed to this issue, particularly given the complexity of withdrawing a drug with mixed efficacy data and a positive safety profile, and welcome the opportunity to discuss an appropriate phase-down plan for patients,” he added. .
Makena is a synthetic version of progesterone, a hormone needed to maintain a pregnancy, and has been the only drug approved by the FDA to reduce the risk of giving birth prematurely. Administered in weekly injections starting at 16 weeks of pregnancy, it is intended for women who have given birth prematurely.
The FDA’s initial accelerated approval came in 2011 after a 500-person study indicated the drug helped women who had given birth early, with the caveat that Covis had to do more research to confirm that the drug helped. medication helped create healthier babies.
In 2019, another study, this one of 1,700 people, failed to show a reduction in preterm births or a healthier infant outcome. Last October, a board of external FDA advisors voted to recommend withdrawing the agency’s approval.
The FDA still plans to continue with its own process to recall it despite the Covis announcement. The final decision will be made by FDA Commissioner Robert Califf, with input from the agency’s chief scientist.
Some groups, including the American College of Obstetricians and Gynecologists, had urged the FDA to keep the drug in circulation pending further investigation. The organization had no comment Wednesday.
About 10% of births occur before 37 weeks gestation, which can lead to serious health problems and possible death. There is a higher rate of premature birth among black women.
with cable news services