Biogen has developed SKYCLARYS® (omaveloxolone), marking a significant breakthrough as the inaugural therapeutic option for addressing Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older.
SKYCLARYS stands as the first treatment authorised within the European Union for this rare, genetic, progressive neurodegenerative disease. Clinical evidence has demonstrated that treatment with SKYCLARYS resulted in enhanced patient function compared to a placebo.
Patients afflicted with Friedreich’s ataxia who received SKYCLARYS during the clinical trials witnessed substantial and clinically meaningful enhancements in their daily lives. This approval instills optimism within the FA community, suggesting that SKYCLARYS holds the potential to revolutionise the management of this debilitating condition.
Friedreich’s ataxia ranks as the most prevalent inherited ataxia, typically manifesting its initial symptoms during childhood, such as progressive coordination loss, muscle weakness, and fatigue. As the disease advances, individuals with FA may encounter additional challenges including vision and hearing impairment, speech and swallowing difficulties, diabetes, scoliosis, and severe heart complications.
Many FA patients rely on mobility aids and often transition to wheelchair usage within 10-20 years post-diagnosis. Unfortunately, FA-related complications significantly curtail life expectancy, with an average survival age of 37 years.
Biogen has obtained approval from the european commission for SKYCLARYS® (omaveloxolone), marking the first therapy for addressing friedreich’s ataxia.
