Pharma Focus Asia

Biogen Developed SKYCLARYS® (omaveloxolone), the First Therapy to treat Friedreich’s Ataxia

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.

magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Advance DoE WorkshopNitrosamine Advance Workshop 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals ConferencePharma Quality Excellence Awards 20244th Annual Pharma GMP Quality Management 20243rd World ADC Asia 2024LogiPharma Asia 2024