European Commission grants standard marketing approval for Fampyra (prolonged-release fampridine tablets) to improve walking for MS patients on the basis of ENHANCE study.-Biogen

The European Commission (EC) has granted a standard marketing authorization for Fampyra (prolonged-release fampridine tablets) for walking improvement in people with multiple sclerosis (MS), Biogen has announced. 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.

ENHANCE is the largest and longest randomized trial of Fampyra, included patients with primary-progressive, secondary-progressive, progressive-relapsing and relapsing-remitting MS. Results, first reported in 2016, show that over 24 weeks: 1. Significantly more Fampyra patients achieved a clinically meaningful improvement in walking ability compared to patients taking placebo (43.2% vs. 33.6%, respectively; p=0.006), as measured by the self-reported 12-Item MS Walking Scale (MSWS-12), the primary endpoint. 2. Significantly more Fampyra patients experienced improved mobility compared to those taking placebo, as measured by a mean improvement in the clinician-reported timed up and go (TUG) speed from baseline (43.4% vs. 34.7%, respectively; p=0.03). 3. Fampyra patients demonstrated greater improvements in the Multiple Sclerosis Impact Scale-29 (MSIS-29) physical score, a self-reported measure of the physical impact of MS, than those treated with placebo (-8.00 vs. -4.68, respectively; p<0.001).The positive effects of Fampyra on improving balance and upper limb dexterity compared to placebo were also observed; however, these results were not statistically significant. The benefit-risk profile of Fampyra remains positive.