The EC granted full marketing approval for Biogen’s Fampyra® (prolonged-release fampridine) as a treatment to improve walking in people with multiple sclerosis (MS). Clearance in Europe was based on the Phase III placebo-controlled ENHANCE trial, which was carried out after the EC granted conditional marketing authorization for Fampyra in 2011.
The ENHANCE trial showed that significantly greater numbers of Fampyra-treated patients than placebo-treated patients achieved clinically meaningful improvements in walking ability measured by the self-reported 12-item MS Walking Scale. Significantly more Fampyra patients also demonstrated improved mobility measured as clinician-reported Timed Up and Go (TUG) Test speed and greater improvements in the Multiple Sclerosis Impact Scale-29 (MSIS-29) physical score.
“Fampyra is a valued medication among MS patients and physicians that addresses one of the most prevalent and disruptive symptoms of the disease,” stated Ferenc Tracik, M.D., vp, EU+ Medical Affairs. “The approval of the standard marketing authorization 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 negotiated global, ex-U.S. rights to develop and commercialize Fampyra from Acorda Therapeutics in 2009. The firm reported Fampyra product revenues of $20.5 million in Q1 2017, up 0.9% on Q1 2016 figures.
Acorda won FDA approval for the drug, which is trademarked Ampyra™ in the U.S., in 2010. The firm reported Ampyra-related net revenues of $112.0 million in the first quarter of 2017, up 2% on the equivalent period in 2016.
Acorda will lose patent protection for Ampyra in July 2018 unless it can successfully appeal a federal court’s decision in April to invalidate the majority of its Ampyra patents.