Biogen’s SKYCLARYS becomes first approved treatment for Friedreich’s Ataxia in EU

Biogen’s SKYCLARYS becomes first approved treatment for Friedreich’s Ataxia in EU

In a landmark decision, the European Commission (EC) has authorized Biogen Inc.’s SKYCLARYS (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. This approval heralds SKYCLARYS as the first medication sanctioned within the European Union for this rare, genetic, and progressively debilitating neurodegenerative disease, promising a new […]

Reata Pharmaceuticals gets Skyclarys FDA approval for Friedreich’s Ataxia

Reata Pharmaceuticals gets Skyclarys FDA approval for Friedreich’s Ataxia

Reata Pharmaceuticals has secured the approval of the US Food and Drug Administration (FDA) for Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia, a neuromuscular disease. Skyclarys is an oral, once-daily medication indicated for the treatment of Friedreich’s ataxia in adults and adolescents aged 16 years and older in the US. Patients are recommended to […]