By Manas Mishra
(Reuters) – Advisers to the U.S. Food and Drug Administration on Wednesday voted in favor of removing Covis Pharma’s drug for preventing preterm birth from the market several years after its approval, following a failed study.
The FDA has been pushing to withdraw the drug, Makena, since 2020, while Covis insists the regulator wait for data from another confirmatory study and narrow its use in the meantime.
It argues that the previous study had flaws as it was conducted in a low-risk population.
Makena and its generic versions are the only approved treatments for reducing the risk of preterm birth, which affects one in every 10 babies in the United States.
The committee voted 14-1 that the FDA should withdraw the drug after voting against the drug’s effectiveness.
The drug, Makena, was approved in 2011 under the FDA’s “accelerated approval” pathway – which allows for therapies that treat untreated medical conditions to enter the market without strong evidence they work.
“I do not think FDA should allow Makena to remain on the market, and doing so would introduce complete regulatory chaos,” said Mark Hudak, a panel member.
The pathway has come under scrutiny since the agency granted accelerated approval to Biogen Inc’s Alzheimer’s disease treatment Aduhelm against the advice of its advisory panel. Over 280 drugs have been granted accelerated approval since the pathway was established in 1992.
Makena, a hormonal medicine, was approved based on data that showed it reduced the rate of preterm deliveries, rather than evidence that it improved the health of babies.
Private equity-backed Covis gained the drug through a $647 million deal for Amag Pharmaceuticals, the seller of Makena, in 2020.
(Reporting by Manas Mishra in Bengaluru; Editing by Shinjini Ganguli)
