Makena saga nears an end as Covis requests to pull controversial preterm birth drug
Luxembourg-based Covis Pharma has been in a tug of war with the FDA over whether to pull its controversial preterm birth drug Makena, which won an accelerated approval in 2011 but failed its confirmatory trial in 2018.
After two failed adcomms, Covis is now waving the white flag and agreeing to pull the drug from the market, according to documents posted this afternoon.
The decision from Covis follows a 14-1 vote from the FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee last October to pull the drug, which failed to confirm the drug’s benefit for babies or mothers.
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