No FDA AdComm Meeting on Omaveloxolone NDA for Friedreich’s Ataxia

Reata Pharmaceuticals said that the FDA told the company that there will not be an advisory committee meeting held to review the company’s New Drug Application (NDA) for Omaveloxolone, the company’s investigational drug to treat Friedreich’s ataxia, a rare, genetic, life-shortening, degenerative neuromuscular disorder for which there are currently no approved therapies.

In August, the agency extended the review period for the NDA by three months, setting the new decision date at Feb. 28, 2023.

The FDA has granted omaveloxolone Orphan Drug, Fast Track and Rare Pediatric Disease Designations. An estimated 5,000 children and adults in the United States and 22,000 individuals globally have the disease.

Friedreich’s ataxia symptoms typically start in childhood. They include progressive loss of coordination, muscle weakness, visual impairment, hearing loss, diabetes, cardiomyopathy and fatigue. Patients usually need a wheelchair in their twenties and die in their mid-thirties.