Posted by Michael Wonder on 18 Dec 2023
CHMP issues positive opinion for Biogen’s Skyclarys (omaveloxolone), the first therapy to treat Friedreich’s ataxia, a rare neurodegenerative disease
15 December 2023 - Biogen announced the CHMP of the EMA recommended marketing authorisation for Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia in people aged 16 years and older.
If approved by the European Commission, Skyclarys will be the first treatment authorised within the European Union for this rare, genetic, progressive neuromuscular disease.
