Biogen gains full EU approval for MS drug Fampyra

The European Commission has granted a standard marketing authorization for Fampyra (prolonged-release fampridine tablets) for walking improvement in people with multiple sclerosis (MS), said the drug’s maker, Biogen (Nasdaq: BIIB), whose shares gained 2.1% to $253.33 by close of trading on Wednesday.

The approval is based on the results of the Phase III ENHANCE study, which confirm the clinically-meaningful benefits and safety of Fampyra over the long term in people with both relapsing and progressive forms of MS. The ENHANCE study was conducted following the EC’s conditional marketing authorization for Fampyra in 2011. Fampyra can be used alone or with existing MS therapies, including immunomodulatory drugs.

“Approximately 80 percent of people with MS experience walking impairment, one of the most common issues with the disease. We frequently hear from people living with MS that these walking challenges affect their independence, restrict their ability to work and negatively impact their overall quality of life,” said Jeremy Hobart, consultant neurologist at Plymouth Hospitals NHS Trust and professor of Clinical Neurology and Health Measurement at the Plymouth University Peninsula Schools of Medicine and Dentistry. “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.”