EU Grants Standard Marketing Authorization for Fampyra to Improve MS Walking Impairment

The European Commission has granted standard marketing authorization for Fampyra to improve walking in adult patients with multiple sclerosis (MS).

Fampyra can be used as a monotherapy or in combination with disease-modifying therapies, including immunomodulatory drugs, according to a Biogen press release.

The approval is based on results from the phase 3 ENHANCE study, which evaluated the long-term safety and efficacy of Fampyra in improving walking in patients with MS who have walking disabilities.

“Approximately 80% of people with MS experience walking impairment, one of the most common issues with the diseases,” Jeremy Hobart, PhD, consultant neurologist at Plymouth Hospitals NHS Trust, professor of Clinical Neurology and Health Measurement at Plymouth University Peninsula Schools of Medicine and Dentistry, said in a release. “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.”

ENHANCE is the largest and longest randomized trial of Fampyra, and consisted of patients with primary progressive, secondary progressive, progressive relapsing, and relapsing-remitting MS.

After 24 weeks, the results of the study showed that patients administered Fampyra achieved significantly more clinically meaningful improvements in walking ability compared with patients who received a placebo.

Patients in the Fampyra arm experienced significantly more improvements in mobility compared with the placebo arm. They also demonstrated greater improvements in the Multiple Sclerosis Impact Scale-29 physical score than patients who received the placebo.

Although Fampyra demonstrated positive effects on improving balance and upper limb dexterity compared with placebo, these results were not statistically significant. The benefit-risk profile of Fampyra remains positive, according to the release.

The most common adverse events are urinary tract infection, asthenia, back pain, pharyngolaryngeal pain, and dyspnea.

“Fampyra is a valued medication among MS patients and physicians that address one of the most prevalent and disruptive symptoms of the disease,” Ferenc Tracik, MD, vice president of European Medical Affairs, said in a release. “The approval of the standard marketing authorization of 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.”