(Reuters) -The U.S. Food and Drug Administration (FDA) on Thursday withdrew its approval for Covis Pharma’s preterm birth prevention drug, Makena, saying that the drug was not effective in treating the complication.
The U.S. health regulator has been pushing to withdraw the drug since 2020, while Covis insisted that the FDA wait for data from another confirmatory study and narrow its use in the meantime.
In March, the company had voluntarily withdrawn its application for full approval of the drug and said it would outline its plan for winding-down supplies from the market after a final decision from the FDA.
The drug was granted accelerated approval in 2011 but ensuing studies did not verify the clinical benefit of the drug.
In October, a panel of external advisers to the FDA had almost unanimously recommended to withdraw the drug from the market after a failed study.
(Reporting by Khushi Mandowara in Bengaluru; Editing by Rashmi Aich)
