Biogen's Skyclarys Approved In Europe For Friedreich's Ataxia Treatment

(RTTNews) - Biogen Inc. (BIIB) said that the European Commission has authorized Skyclarys (omaveloxolone) for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.

Skyclarys is the first treatment approved within the European Union for this rare, genetic, progressive neurodegenerative disease.

Friedreich's ataxia is the most common inherited ataxia. Early symptoms typically appear in childhood and include progressive loss of coordination, muscle weakness, and fatigue.

Skyclarys (omaveloxolone) 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 U.S. and European Union. Skyclarys received Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the U.S. Food and Drug Administration. The European Commission granted Orphan Drug designation in Europe to Skyclarys for the treatment of Friedreich's ataxia.

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