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FDA panel recommends revoking the approval of controversial drug for preterm births

Makena, the only drug approved to prevent premature births, has not shown to be effective and exposes women to “serious risk," the agency's scientists said.
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An advisory panel to the Food and Drug Administration voted Wednesday to take a drug intended to prevent premature births off the market, saying that it remains doubtful that the drug works.

The recommendation, in a 14-1 vote, from the agency’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee closed a three-day meeting on the clinical trial evidence supporting Makena, the only drug approved in the U.S. to prevent preterm births.

The meeting included emotional testimony, including from advocates who said removing the drug could deepen maternal health inequities.

The panel voted on three questions: whether the drug is effective, whether trial data support its approval and whether it should remain on the market. The panel voted no on each question.

“It would be unfair to keep the drug on the market and expose especially vulnerable populations to an ineffective therapy,” said panel member Dr. Mark Hudak, a pediatrician at the University of Florida College of Medicine in Jacksonville.

Preterm birth is when a baby is born before 37 weeks, and occurs in about 1 in 10 births in the U.S., according to the Centers for Disease Control and Prevention. Black women in the U.S. are at higher risk for the complication, which can cause chronic health problems for babies throughout their lives.

Makena is a synthetic hormone administered weekly, usually beginning at 16 weeks of pregnancy.   

Wednesday’s recommendation is largely based on 2019 clinical trial data of more than 1,500 women who received a weekly injection of Makena, beginning at 16 weeks of pregnancy, or a placebo. The trial found that the drug failed to reduce the risk of preterm births or produce better health outcomes for newborns.

The panel’s vote doesn't mean the drug will be removed from the market; that decision is left to the FDA, which could make its final decision within a few months. 

The agency, however, has already proposed revoking the drug’s approval once before.

The drug received accelerated approval from the FDA in 2011 based on a smaller clinical trial of more than 500 women, which appeared to show a benefit. However, the approval was on the condition that the manufacturer, AMAG Pharmaceuticals, conduct an additional trial to prove that the drug works.

Makena by Covis Pharma.
Makena by Covis Pharma. Covis Pharma via AP

When a 2019 trial showed that the drug produced no benefits, the same FDA advisory panel voted to revoke the drug's approval.

Then, the FDA, a year later, proposed taking the drug off the market, but Covis Pharma, now the manufacturer of Makena, requested an additional hearing to make its case.

In slides published ahead of this week's meeting, FDA scientists did not change their stance on the drug, saying Makena has not shown to be effective and exposes women to "serious risk," including blood clots, allergic reactions and depression.

What's more, "retaining Makena’s approval likely hinders study of more promising treatments for preterm birth," FDA scientists wrote.

During the three-day meeting, company representatives maintained that its drug remains an "essential tool" for preventing preterm births.

The company proposed to panel members that the FDA keep Makena on the market while it conducts another clinical trial that could prove the drug's benefits.

It also proposed a partial withdrawal of the drug, making the drug only available to women at the highest risk of preterm birth.

"Covis is committed to working with the agency to consider appropriate options for further study, including a properly designed and well-control clinical trial, an observational study and narrowing the labeling to focus the indication on the most high-risk patients," the company said in a statement before the vote.

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