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December 21, 2022
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VIDEO: FDA poised to withdraw preterm birth drug from market

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The FDA “appears poised” to withdraw the only drug indicated for the prevention of preterm birth from the market following a recent recommendation to do so.

The drug — Makena (hydroxyprogesterone caproate injection, Covis Pharma) — originally entered the market in 2011 through the FDA’s accelerated approval process.

“In exchange [for accelerated approval], companies must conduct confirmatory trials to show that the drug actually works,” Daniel G. Aaron, MD, JD, the Heyman fellow at Harvard Law School, told Healio. In 2019, the findings of a confirmatory trial were published, and an advisory committee agreed that the data “did not confirm clinical benefit,” according to Aaron and colleagues’ Viewpoint in JAMA.

However, Makena has not been removed from the market in the 3 years since the findings were presented. According to Aaron, the nature of the accelerated approval process makes this more difficult.

“There is talk about the need for a change to accelerated approval to make it easier to pull out drugs from the market that are not working, that confirmatory trials fail to corroborate,” Aaron said.

A second issue is that there are conflicting opinions on Makena’s effectiveness among clinicians themselves.

“Some OB/GYN providers continue to use Makena in very high-risk patients with the logic that maybe these patients stand to benefit more from the drug,” Aaron said. “While that may be the case, FDA did a subgroup analysis and believes that the drug does not work in any subgroup.”

In this video interview, Aaron also highlights issues with the withdrawal process for drugs that undergo the FDA’s accelerated approval as a whole and advises providers on the best course of clinical action while the Makena withdrawal is “in limbo.”

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