Biogen’s Fampyra receives new EU approval for mobility benefits

Biogen has announced that its multiple sclerosis drug Fampyra has been approved in Europe as a means of enhancing mobility among sufferers of the disease.
 
The European Commission has granted a standard marketing authorisation for Fampyra for walking improvement in people with multiple sclerosis, either when used alone or in conjunction with other therapies.
 
This approval is based on the results of the phase III ENHANCE study, which confirmed the clinically meaningful benefits and safety of Fampyra over the long term in people with both relapsing and progressive forms of multiple sclerosis.
 
Around 80 percent of people with this condition experience walking impairment, making it one of the most common issues with the disease. Studies have shown that Biogen's drug can provide significant improvements in walking ability, as well as in broader aspects of quality of life.
 
Dr Ferenc Tracik, vice-president for European medical affairs at Biogen, said: "The approval of the standard marketing authorisation for Fampyra is validation of the substantial difference this therapy has made on the lives of people with multiple sclerosis."
 
Biogen has a licence from Acorda Therapeutics to develop and commercialise Fampyra in all markets outside the US.
 
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