FDA panel recommends revoking the approval of a controversial drug intended to prevent premature birth


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A panel of U.S. Food and Drug Administration advisors voted this week to revoke the approval of a controversial drug intended to prevent premature birth in women at risk of preterm labor, citing dangers associated with the drug’s use. The vote was 10-1 against the drug, called 17P, according to multiple reports. The FDA isn’t required to follow the recommendations of its advisory committees but typically does so. Friday’s vote reportedly marks the first time since 2001 that an FDA advisory committee has voted to rescind approval of a drug already on the market in the United States…

A medicine meant to stop preterm births was taken off the market by an advisory council to the Food and Drug Administration on Wednesday, noting that its effectiveness is still in question.

The agency’s Obstetrics, Reproductive and Urologic Drugs Advisory Committee adopted the suggestion by a vote of 14 to 1 at the end of a three-day conference on the clinical trial data supporting Makena, the only medication authorised in the US to prevent premature births.

At the hearing, there was emotive testimony from activists who warned that withdrawing the medicine might worsen maternal health disparities.

The three issues up for voting were whether the medication is efficient, if the trial statistics support its approval, and whether it ought to stay on the market. On each issue, the panel voted against it.

Dr. Mark Hudak, a paediatrician at the University of Florida College of Medicine in Jacksonville, remarked as a panellist, “It would be unjust to keep the medicine on the market and expose especially vulnerable groups to an inadequate therapy.”

According to the Centers for Disease Control and Prevention, preterm birth happens in around one in ten births in the United States when a baby is born before 37 weeks. Black women in the United States are more likely to have the condition, which can result in long-term health issues for unborn children.
Makena is a synthetic hormone that’s normally started from week 16 of pregnancy and given once a week.
The advice for Wednesday is mostly based on 2019 clinical trial data of more than 1,500 women who got Makena or a placebo once a week starting at 16 weeks of pregnancy. The medicine did not improve the health of neonates or lower the chance of preterm delivery, according to the trial’s findings.

The FDA, which might reach its final judgement in a few months, will decide whether to take the medicine off the market despite the panel’s vote.
However, the organisation has previously suggested that the drug’s approval be revoked.


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