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Biogen initiates Phase 3 pediatric study of omaveloxolone

Biogen (BIIB) announced the initiation of dosing in the BRAVE study, a global Phase 3 clinical trial. The BRAVE study will evaluate the efficacy and safety of omaveloxolone in children with Friedreich ataxia between the ages of 2 to less than16. Both non-ambulatory and ambulatory participants may qualify for the study. Currently, omaveloxolone is commercialized under the brand name SKYCLARYS in over 40 countries, including in the U.S. and the European Union, and is the only approved product for FA in adults and adolescents aged 16 years and older.

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