RHHBY - FDA forces pre-term birth drug off the market after 12 years

2023-04-06 12:35:54 ET

FDA’s accelerated drug approval program came under scrutiny on Thursday after the agency withdrew its approval for Makena, a drug first cleared the regulatory hurdle more than a decade ago to prevent preterm birth in women.

The FDA approved Makena in 2011 under accelerated approval based on the drug’s effect on an intermediate clinical endpoint that was expected to predict its clinical benefit.

At the time, the developer Luxembourg-based Covis Pharma was required to conduct a post-marketing confirmatory study, which didn’t verify the benefit, and the FDA proposed the drug’s withdrawal from the market in 2020.

However, private-equity-backed Covis appealed the decision, noting that Makena could benefit Black women, who have a higher risk for preterm birth but weren’t well-represented in the follow-up trial.

After two failed attempts to win endorsement from a group of FDA advisors, the company in March decided to withdraw Makena from the market voluntarily.

“Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of being FDA-approved,” FDA Commissioner Robert Califf remarked.

The path leading up to FDA’s decision marks flaws in the FDA’s accelerated pathway under which the regulator clears treatments targeted at unmet medical needs, such as rare diseases or conditions affecting small patient populations.

Companies such as Merck ( NYSE: MRK ) and Biogen ( BIIB )/ Eisai ( OTCPK:ESAIY ) ( OTCPK:ESALF ) are among notable drugmakers that recently benefitted from the FDA’s accelerated path.

Read: In March, the FDA issued a draft guidance that cancer drug developers seeking accelerated approval can use in designing clinical trials.

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