Premature birth drug saga drags on as Covis questions fairness of FDA hearing

It’s been almost three years since the premature birth drug Makena failed to confirm its benefits in a large trial, following an accelerated approval in 2011.

And still, the drug’s sponsor Covis Pharma is battling with the FDA to keep Makena and its generic equivalents marketed in the US as the only FDA-approved medication to reduce premature births. An FDA adcomm voted to pull the drug in October 2019. One year later, FDA called for Makena and its generic versions to be pulled from the market.