Biogen Idec (NASDAQ: BIIB) announced today it has received conditional approval from the European Commission for FAMPYRA® (prolonged-release fampridine tablets) to improve walking in adult patients with multiple sclerosis (MS) who have walking disability (Expanded Disability Status Scale 4-7).
“Functional impairment in MS presents many challenges for patients and walking impairment is one of the most physically and emotionally disruptive aspects. Until now, no approved treatment has existed to address this issue and FAMPYRA should provide patients and clinicians with a welcome new option.”
FAMPYRA is the first treatment that addresses this unmet medical need with demonstrated efficacy in people with all types of MS. FAMPYRA can be used alone or in combination with disease modifying therapies, including immunomodulatory drugs.
"With its approval by the European Commission, FAMPYRA has the potential to make a real difference for thousands of people across Europe with both relapsing remitting and progressive forms of MS," explained Prof. Dr. Bernd C. Kieseier, Department of Neurology, University Hospital Duesseldorf. "Functional impairment in MS presents many challenges for patients and walking impairment is one of the most physically and emotionally disruptive aspects. Until now, no approved treatment has existed to address this issue and FAMPYRA should provide patients and clinicians with a welcome new option."
People with MS consistently rate walking as the most important function throughout the course of their condition. Walking impairment is directly associated with loss of independence, restrictions on a patient's ability to work and a reduction in overall levels of household income.
"Walking disability is one of the most devastating consequences of MS and one of the symptoms MS patients are most concerned about. It can significantly impact quality of life as well as social participation," explained Douglas E. Williams, Ph.D., Executive Vice President, Research and Development at Biogen Idec. "Patients worldwide are benefitting from Biogen Idec's therapies, and FAMPYRA is the third product Biogen Idec is bringing to the MS community in Europe. We are excited to offer patients this novel oral therapy that has been shown to improve walking ability."
FAMPYRA was developed and is being commercialized in the United States by Acorda Therapeutics, Inc. (NASDAQ: ACOR) under the trade name AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. Biogen Idec licensed the rights from Acorda to develop and commercialize fampridine in all markets outside the United States.
"Studies have shown that even small degrees of walking impairment can have a major negative impact on the patient. The European approval of FAMPYRA allows people with MS in the European Union to have access to a novel therapy that has been shown to improve walking ability across a wide range of impairment, from mild to severe," said Ron Cohen, M.D., Acorda's President and CEO. "Since its launch in the United States in 2010, this medication has been prescribed for tens of thousands of people with MS. We will continue to work with our partner Biogen Idec to make it available in other markets around the world."
FAMPYRA enhances neurologic function by improving impulse conduction across demyelinated neurons. In clinical trials, patients responding to FAMPYRA had an average increase in walking speed of 25 percent and FAMPRYA was shown to provide a clinically meaningful improvement in walking.
FAMPYRA will be available in Europe, on a country-by-country basis, beginning with Germany in September 2011, with other countries following.