Fampyra Granted Standard Approval in Europe as Trial Results Support Effectiveness
Fampyra (prolonged-release fampridine tablets) — sold in the U.S. as Ampyra (dalfampridine) — has now been granted standard marketing authorization in Europe. The approval was based on the results of a Biogen-sponsored Phase 3 clinical trial confirming the drug’s safety and efficacy in improving walking in patients with multiple sclerosis (MS).
Fampyra has been on a conditional marketing authorization in the EU since 2011, as the European authorities awaited more safety and effectiveness data.
“Approximately 80 percent of people with MS experience walking impairment, one of the most common issues with the disease. We frequently hear from people living with MS that these walking challenges affect their independence, restrict their ability to work, and negatively impact their overall quality of life,” Jeremy Hobart, PhD, consultant neurologist at Plymouth Hospitals NHS Trust, said in a press release.
The Phase 3 ENHANCE (NCT02219932) study was the largest and longest Fampyra trial to date, and — unlike the majority of other MS trials — included patients with primary progressive, secondary progressive, progressive relapsing, and relapsing-remitting MS. All had moderate to severe disability, with Expanded Disability Status Scale (EDSS) scores of 4.0 to 7.0.
Patients received either 10 mg of Fampyra twice daily or the placebo for 24 weeks. Results, first reported in 2016, showed that Fampyra improved walking and mobility. Patients also reported improvements in a self-reported measure of the physical impact of their disease.
Researchers also noted that Fampyra-treated patients had better balance and improved hand and arm movements, but these differences were not statistically significant.
“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,” said Hobart, who is also a professor of clinical neurology and health measurement at the Plymouth University Peninsula Schools of Medicine and Dentistry.
Biogen holds the license to develop and sell Fampyra in all markets outside the U.S., where the drug’s original developer — Acorda Therapeutics — has kept its rights. In the U.S., Ampyra has been approved to improve walking ability in MS since 2010.
“Fampyra is a valued medication among MS patients and physicians that addresses one of the most prevalent and disruptive symptoms of the disease. 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, MD, vice president, EU+ Medical Affairs at Biogen.
“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,” Tracik added.
In addition to company-sponsored clinical trials, researchers at Switzerland’s University of Zurich recently reported that a long-term trial confirmed the drug’s benefits over a period of more than two years.