Advisers to the Food and Drug Administration on Wednesday recommended that a treatment to prevent women from having preterm births be removed from the market.
Why it matters: Covis' Makena drug is the only one of its kind in the U.S. and has received support from the leading OB-GYN group in the country.
- “The need for an effective treatment for preterm birth is great,” the American College of Obstetricians and Gynecologists said in 2020. “Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition.”
State of play: In a 14-1 vote, the committee said that Makena should not remain on the market while a confirmatory study on the drug is designed and conducted. FDA experts over the past two days presented evidence to the panel that the drug doesn't have clinical benefit.
- The advisors noted there is no reason for the drug to remain on the market without evidence that it's effective.
- The panel voted to say available evidence does not show that Makena is effective at reducing the risk of preterm births.
Catch up fast: An FDA advisory committee voted in 2019 to withdraw the drug — which was approved in 2011 under a fast-track process — after a study found that it is ineffective.
What's next: The FDA will make a final decision on whether to accept the panel's recommendation and pull the drug.
Editor's note: This is a developing story. Please check back for updates.
