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Biogen's SKYCLARYS® Receives Groundbreaking European Commission Approval as the First Treatment for Friedreich’s Ataxia

Biogen recently announced a groundbreaking development: the European Commission has officially authorized SKYCLARYS® (omaveloxolone) for treating Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and older. This marks a significant step forward as SKYCLARYS becomes the first approved treatment for this rare, genetic, and progressive neurodegenerative disease within the European Union.

Patients enrolled in clinical trials for SKYCLARYS experienced notable and meaningful improvements in their daily lives, sparking optimism within the FA community. Friedreich’s ataxia, the most common inherited ataxia, presents with early symptoms typically appearing in childhood, including coordination loss, muscle weakness, and fatigue. 

As the disease progresses, patients may face further complications such as vision and hearing impairment, speech and swallowing difficulties, diabetes, scoliosis, and severe heart conditions. Many individuals with FA rely on walking aids and may eventually require a wheelchair.
The approval of SKYCLARYS offers hope to FA patients and their families, potentially enhancing their quality of life and addressing the diverse challenges posed by the condition. 

With its designations as an Orphan Drug in both the U.S. and Europe, along with Fast Track and Rare Pediatric Disease Designations from the FDA, SKYCLARYS represents a significant breakthrough in managing Friedreich’s ataxia, opening new doors for treatment and support.
 

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