FDA Panel Votes for Removal of Drug Meant to Prevent Preterm Births

WEDNESDAY, Oct. 19, 2022 (HealthDay News) -- A U.S. Food and Drug Administration advisory committee on Wednesday voted to recommend that a controversial drug meant to prevent premature births be pulled from the market.

FDA officials have said they want to withdraw the medication, Makena, because of a lack of evidence that it works and due to its side effects. The drug was initially allowed as part of the agency's accelerated approval program, which lets a medication launch after promising early results while larger studies test it further.

But in a 14-1 vote for removal of the drug, the FDA Obstetrics, Reproductive, and Urologic Drugs Advisory Committee closed a three-day meeting on the evidence supporting Makena. It is the only drug approved in the United States to prevent preterm births.

"It would be unfair to keep the drug on the market and expose especially vulnerable populations to an ineffective therapy," said panel member Mark Hudak, M.D., a pediatrician at the University of Florida College of Medicine in Jacksonville, NBC News reported.

But some groups have defended the drug. "The need for an effective treatment for preterm birth is great," the American College of Obstetricians and Gynecologists says. "Makena and its associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition."

The panel's vote does not mean the drug will be removed from the market, according to NBC News. That decision is left to the FDA, which could make its final decision within a few months.

“As presented during the hearing, we believe that Makena is effective in a higher-risk patient population,” Raghav Chari, Ph.D., chief innovation officer at Covis, said in a press release. “We will work collaboratively with the FDA to clarify the next steps in this process.”

NBC News Article