European Commission Nods Biogen's Skyclarys To Treat Friedreich's Ataxia

Biogen Inc. announced the European Commission (EC) has authorized Skyclarys (omaveloxolone) for the treatment of Friedreich’s ataxia (FA) 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.

“In my clinical practice, I have seen the devastating impact that Friedreich’s ataxia has on patients and their families,” said Sylvia Boesch, M.D., MSc, Principal Investigator of the MOXIe study and Head of the Center for Rare Movement Disorders Innsbruck, Department of Neurology, Medical University Innsbruck, Austria. “Friedreich’s ataxia patients treated with Skyclarys in the clinical trial experienced important and clinically meaningful improvements for their daily lives. With this approval, there is optimism within the community that Skyclarys has the potential to usher in a new era in the management of Friedreich’s ataxia.”

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. As the disease progresses, people living with FA may also experience vision impairment, hearing loss, problems with speech and swallowing, diabetes, scoliosis, and serious heart conditions. Many people with FA use walking aids, and often require a wheelchair within 10-20 years following their diagnosis. Unfortunately, complications from FA contribute to a life expectancy of 37 years on average, as per pharmabiz.

“Biogen is proud to add Skyclarys to our portfolio of medicines and address a significant unmet need by bringing the first treatment to people living with Friedreich’s ataxia in Europe,” said Priya Singhal, M.D., M.P.H., head of development at Biogen. “Our team is committed to engaging with the medical community and local authorities as we work to urgently secure access for patients. We sincerely thank the Friedreich’s ataxia community for their contributions that enabled the development of Skyclarys and made today’s approval possible.”