EC nod for Biogen’s Skyclarys for Friedreich’s ataxia

The European Commission (EC) has authorized Biogen’s (Nasdaq: BIIB) 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. Biogen gained rights to the drug along with its $7.3 billion acquisition of Reata Pharmaceuticals last year. Skyclarys, which has already gained US Food and Drug Administration approval, could bring in over $1 billion in the US at peak, according to Stifel analysts' estimates, based on a list price of $370,000 per year.

“In my clinical practice, I have seen the devastating impact that Friedreich’s ataxia has on patients and their families,” said Dr Sylvia Boesch, 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,” she added.