Reata’s ‘toss up’ drug approval decision is in the unpredictable hands of FDA’s Billy Dunn

In the aftermath of the Food and Drug Administration’s Aduhelm debacle, the agency’s neuroscience chief Billy Dunn has another controversial approval decision to make. It will once again test his willingness to apply the FDA’s doctrine of “regulatory flexibility” to a medicine with less-than-convincing clinical data.

This time, the drug in question is called omaveloxolone, which its maker Reata Pharmaceuticals is developing as a treatment for people with Friedreich’s ataxia (FA), a rare, neurological disease that causes progressive damage to the brain, nervous system, and muscles. Over time, people born with FA lose the ability to talk, use fine motor skills, or walk. The average life expectancy for a person with FA is in the mid-30s, and there are no currently approved treatments.

The FDA’s neuroscience office, led by Dunn, is expected to render its decision on omaveloxolone by Feb. 28. It’s a pivotal moment for Reata, which has struggled to push drugs across the finish line. “Omav” is no exception. By the company’s own admission, FDA staff conducting the review have raised concerns about the strength of evidence supporting omav’s efficacy as a treatment for FA.

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