Biogen Idec has been boosted by the news that it has received conditional approval from the European Commission for Fampyra, which improves walking in patients with multiple sclerosis.
The company notes that Fampyra (prolonged-release fampridine) is the first treatment that addresses "this unmet medical need with demonstrated efficacy in people with all types of MS". The treatment can be used alone or in combination with disease-modifying therapies, including immunomodulatory drugs.
The approval comes on the back of the European Medicines Agency's decision in May to overturn an earlier negative decision on Fampyra. However, the green light is conditional on Biogen carrying out a further study to find out more about the medicine’s benefits and safety in the long term and beyond its effects on walking speed. A conditional marketing authorisation is renewable annually.
Douglas Williams, head of R&D at Biogen, noted that walking disability "is one of the most devastating consequences of MS" and one of the symptoms patients are most concerned about as "it can significantly impact quality of life as well as social participation".
Fampyra was developed and is being sold in the USA by Acorda Therapeutics, as Ampyra (dalfampridine). The latter's chief executive Ron Cohen noted that since its launch across the pond in 2010, "this medication has been prescribed for tens of thousands of people with MS".
Biogen added that Fampyra will be made available in Europe, on a country-by-country basis, beginning with Germany in September. The company told PharmaTimes World News that in line with other MS products, it expects Fampyra to be available in Europe at approximately half the price of the product in the USA; across the Atlantic, the manufacture price is around $14,000 per year.