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Biogen Received European Commission Approval for SKYCLARYS® (omaveloxolone), the First Therapy to Treat Friedreich’s Ataxia | ||||||||||||
By: GlobeNewswire - 12 Feb 2024 | Back to overview list |
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CAMBRIDGE, Mass., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) 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.1 “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.2,3 Early symptoms typically appear in childhood and include progressive loss of coordination, muscle weakness, and fatigue.4 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.5 Many people with FA use walking aids, and often require a wheelchair within 10-20 years following their diagnosis.2 Unfortunately, complications from FA contribute to a life expectancy of 37 years on average.5-7 “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.” The EC approval of SKYCLARYS is based on efficacy and safety data from the placebo-controlled MOXIe Part 2 trial. At the end of the 48-week study, patients who received SKYCLARYS had significantly improved modified Friedreich Ataxia Rating Scale (mFARS) scores relative to placebo. All components of the mFARS assessment, including ability to swallow (bulbar), upper limb coordination, lower limb coordination, and upright stability, favored SKYCLARYS over placebo. Additional exploratory data was provided from a post hoc, propensity-matched analysis in which patients treated with SKYCLARYS in MOXIe (Extension) had lower mFARS scores at 3 years, as compared to a matched natural history group. The most common side effects are increased liver enzymes, decreased weight and appetite, nausea, vomiting, diarrhea, headache, fatigue, oropharyngeal and back pain, muscle spasms, and influenza. “The European Commission approval of SKYCLARYS is a significant milestone toward expanding global access, bringing the first approved treatment to the Friedreich’s ataxia community in the EU,” said Jennifer Farmer, Chief Executive Officer of the Friedreich’s Ataxia Research Alliance (FARA). “FARA is grateful to all the researchers, clinical sites, individuals with Friedreich’s ataxia and their families, patient organizations, Biogen and the European Medicines Agency for the research, drug development and advocacy efforts that led to this approval. We look forward to continuing our collaboration with the Friedreich’s ataxia community with the goal of expanding access where it is needed.” “On behalf of Euro-ataxia and its members, I am delighted to welcome the European Commission approval of SKYCLARYS, a much-needed medicine for adults with Friedreich’s ataxia in EU countries,” said Andreas Nadke, President of Euro-ataxia. “Our member’s patient groups have been working and waiting for this day for many years, and we firmly believe that this will be a successful and gratifying beginning in the treatment of Friedreich’s ataxia.” For detailed product information, please see the Summary of Product Characteristics on the European Medicines Agency website at www.ema.europa.eu. Biogen is committed to working closely with all stakeholders to ensure that eligible European patients can have access to this treatment. Early access programs for SKYCLARYS are currently open in Germany and France, with plans to expand to additional countries where possible. SKYCLARYS is also approved for use in the United States, and Biogen is engaging with regulatory authorities in other regions. About SKYCLARYS® (omaveloxolone) About Friedreich’s Ataxia About Biogen Biogen Safe Harbor These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen’s drug candidates, including omaveloxolone; actual timing and content of submissions to and decisions made by the regulatory authorities regarding omaveloxolone; uncertainty of success in the development and potential commercialization of omaveloxolone; failure to protect and enforce Biogen’s data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen’s business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements. References:
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