Biogen’s Fampyra has been granted a standard approval by European regulators on the back of late-stage data supporting its use to improve walking in patients with multiple sclerosis.
The drug won conditional approval back in 2011 on the back of promising data on its benefit, which was subsequently confirmed in the Phase III ENHANCE trial.
According to the results, significantly more patients taking Fampyra (fampridine) achieved a clinically meaningful improvement in walking ability compared to patients taking placebo (43.2 percent versus 33.6 percent, respectively).
Also, significantly more Fampyra patients (43.4 percent) experienced improved mobility compared to those taking placebo (34.7 percent), and showed greater improvements in the Multiple Sclerosis Impact Scale-29 than those treated with placebo (-8.00 versus -4.68).
“For the past several years, Biogen has been focused on ensuring that Fampyra is available to MS patients in Europe who experience walking disability,” said Ferenc Tracik, vice president, EU+ Medical Affairs.
“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 MS, and speaks to our deep, long-standing commitment to the MS community.”
Biogen has a license from Acorda Therapeutics to develop and commercialise Fampyra in all markets outside the US.