FDA lays the finishing touches on its plan to pull Makena

FDA is going to be issuing its final decision soon on whether or not to pull the longstanding accelerated approval for Covis’ controversial prenatal drug Makena, while another nail is driven into the drug’s coffin.

CDER deputy director Celia Witten wrote in a report summary on the FDA’s adcomm meeting on Makena to FDA Commissioner Robert Califf and chief scientist Namandjé Bumpus Friday that she does not believe that Makena “has been shown to be effective,” either in the current population or a more limited population for the drug that Covis proposed.

Citing known risks and the potential for additional risks, Witten echoed the nearly unanimous adcomm, “I do not think there is a favorable benefit-risk profile to support Makena’s remaining on the market and recommend approval be withdrawn.”

The drug was approved under the accelerated approval pathway in 2011 to lower the chances of a second preterm birth, defined as delivery of a baby before 37 weeks. While data pre-approval showed that fewer women delivered prematurely on the drug in a surrogate endpoint, a confirmatory trial needed to show that Makena both reduced the risk of premature birth and was helpful for a newborn’s health.

However, the trial saw no difference in the proportion of women delivering before 35 weeks between the Makena and placebo, and not any difference in the rate that infants experienced at least one complication from being born prematurely.

After an adcomm proposed the first time that the FDA remove Makena from the market in 2019 in a 9-7 vote, CDER then formally proposed withdrawing the approval for the drug in 2020, kicking off a multi-year process that has included a second adcomm vote. The adcomm held last year voted 14-1 that Makena should not remain on the market.

Celia Witten

A spokesperson for Covis tells Endpoints News that “Covis Pharma is currently reviewing the public hearing report summary and recommendation provided by the hearing’s presiding officer, Dr. Celia Witten. We appreciate the opportunity, as noted within the report, to submit comments addressing the substance of Dr. Witten’s recommendation. Covis plans to respond within the time frame set by the FDA and remains committed to working collaboratively throughout the remainder of the agency’s decision-making process.”

The report added that both Covis and CDER have until March 6 to submit a brief to the docket with arguments and analysis about the report, presentations and discussions at the adcomm, and the committee’s recommendation. Both Califf and Bumpus will consider the submissions before they make the final decision.

Read More