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Fampyra Granted Standard Approval in Europe as Trial Results Support Effectiveness

May 30, 2017

Sold in the U.S. as Ampyra (dalfampridine), Fampyra has now been granted standard marketing authorization in Europe. The drug’s safety and efficacy led to its approval based on results of a Biogen sponsored Phase 3 ENHANCE clinical trial. The drug improved walking in patients with multiple sclerosis (MS). The trial was the largest and longest Fampyra trial, and included patients with primary progressive, secondary progressive, progressive relapsing, and relapsing-remitting MS. Patients received either 10mg of Fampyra twice daily or the placebo for 24 weeks. Results showed improved walking and mobility, and improvements in a self-reported measure of the physical impact of the disease. The patients also had better balance and improved hand and arm movements.

“Results from the ENHANCE study provided additional evidence that Fampyra is an effective treatment for MS and echo what I and other clinicians have observed in treating people with MS: Fampyra provides a clinically significant improvement in walking ability as well as on broader aspects of quality of life,” said Hobart, who is also a professor of clinical neurology and health measurement at the Plymouth University Peninsula Schools of Medicine and Dentistry.

Biogen holds the license to develop and sell Fampyra in all markets outside the U.S. According to Ferenc Tracic, MD, vice president of EU+ Medical Affairs at Biogen, stated that “for the past several years, Biogen has been focused on ensuring that Fampyra is available to MS patients in Europe who experience walking disability.” Fampyra has been on a conditional marketing authorization in the EU since 2011, as the European authorities awaited more safety and effectiveness data. In addition to these successful trials, researchers at Switzerland’s University of Zurich recently reported that a long-term trial confirmed the drug’s benefits over a period of more than two years.

Via MS NEWS TODAY