FDA approval of Skyclarys the first and only drug indicated for patients with Friedreich’s atxia
Reata Pharmaceuticals, Inc., a biopharmaceutical company focused on developing and commercializing novel therapies for patients with severe diseases, announced that the FDA has approved Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older
With this approval, the FDA granted a rare pediatric disease priority review voucher.
“Friedreich's ataxia is a debilitating neuromuscular disease that progressively robs patients of their mobility and independence,” said Susan Perlman, MD, Clinical Professor, Department of Neurology, David Geffen School of Medicine, UCLA. “The approval of Skyclarys represents an important step forward in the treatment of Friedreich's ataxia, providing physicians with the first disease-specific treatment option approved for patients living with this ultra-rare and progressive disease.”
The approval of Skyclarys is supported by the efficacy and safety data from the MOXIe Part 2 trial and a post hoc Propensity-Matched Analysis of the open-label MOXIe Extension trial.
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