FDA Panel Votes to Yank Preterm Birth Drug Off Market

WASHINGTON — An advisory panel to the Food and Drug Administration voted Wednesday to recommend that a drug intended to prevent women from having preterm births be removed from the market.

Makena, manufactured by Covis Pharma, is the only approved treatment to reduce the risk of recurrent preterm birth in women who have a history of spontaneous preterm birth. 

Because this patient population literally had no other treatment to turn to, the FDA granted Makena accelerated approval in 2011 based on positive findings from a placebo-controlled trial with 463 participants.

But concerns about the treatment’s effectiveness lingered, and in 2019, the FDA’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee voted 9-7 to withdraw Makena’s approval after confirmatory trials failed to show it was any more effective than a placebo.

Covis Pharma appealed and asked that a hearing be scheduled to allow it to fight for the treatment’s future.

In doing so, Covis CEO Michael Porter said, “We stand ready to work collaboratively with the agency to address methods of more fully understanding and maintaining this important treatment option for this high-risk, underrepresented, principally minority patient population. 

“Preterm birth is an increasing health issue in the U.S., with preterm birth rates significantly higher than in other developed countries. We believe that a thorough review of the benefits of Makena, particularly among at-risk, disadvantaged communities, is required,” Porter said.

That hearing began on Monday and concluded Wednesday. Over the past two-and-a-half days, the committee heard arguments for and against the drug, and ultimately agreed there is no reason for the drug to remain on the market if there is no evidence that shows that it is effective.

In a 14-1 vote, the panel said the drug should be yanked from the market while a confirmatory study on the drug is designed and conducted.

A spokeswoman for the FDA told The Well News via email that everything the agency has to share about the Makena Hearing will be added to the docket on Regulations.gov.

Asked what will happen next, Shannon Hatch, a spokeswoman for the agency, said, “Within 45 days after the transcript of the hearing becomes available and is posted to the docket, the presiding officer plans to issue and post a report reflecting the recommendations of the advisory committee and her own views based on the presentations at the hearing. 

“The Center for Drug Evaluation and Research and the sponsor will then have 45 days to comment on the report. FDA’s commissioner and chief scientist will review those submissions and the rest of the administrative record in making their decision for the agency and plan to do so expeditiously,” Hatch said.

Dan can be reached at [email protected] and @DanMcCue