US FDA withdraws approval for Makena, Covis Pharma’s preterm birth prevention drug

The US Food and Drug Administration (FDA) withdrew its approval for Covis Pharma’s preterm birth prevention drug, Makena, saying that the drug was not effective in treating the complication.

The US FDA has been pushing to withdraw the drug since 2020 but Covis insisted that the FDA wait for data from another confirmatory study and narrow its use in the meantime.

The withdrawal of the clearance for Makena provided under the accelerated approval pathway, will also apply to cheaper copycat versions of the drug, the FDA said in a statement.

In March, Covis had voluntarily withdrawn its application for full approval of the drug and said it would outline its plan for winding-down supplies from the market after the regulator made a final decision.

The FDA advised patients to talk to their healthcare provider while recognising that there is a supply of Makena and its generics that have already been distributed.

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 US.

The drug was granted accelerated approval in 2011 but ensuing studies did not verify the clinical benefit of the drug. Private equity-backed Covis gained the drug through a $647 million deal for Amag Pharmaceuticals, the seller of Makena, in 2020.

In October, a panel of external advisers to the FDA had almost unanimously recommended withdrawal of the drug from the market after a failed study.

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.

(Edits by EP News Bureau)