Acorda taking over global marketing of Fampyra, MS walking aid
Biogen ending right to sales outside US of treatment also known as Amprya
Fampyra (fampridine), an approved oral treatment to improve the walking abilities of adults with multiple sclerosis (MS), soon will be sold by Acorda Therapeutics worldwide.
The announcement follows the decision by Biogen to terminate a licensing agreement that gave it global development and marketing rights in regions outside the U.S. Acorda, the therapy’s initial developer, remains responsible for sales in the U.S., where it is marketed as Ampyra (dalfampridine). Generic forms of the medication also are available.
With the termination, effective Jan. 1, 2025, all marketing rights will belong to Acorda. The two companies are working together on the transition, with Acorda expecting to assume wider sale responsibilities this year.
Ampyra, which helps in walking with MS, was approved in US in 2010
“We are excited to bring Fampyra in-house, which we believe will add value to Acorda, and allow us to continue to provide access to this important medication for people with MS around the world,” Ron Cohen, MD, Acorda’s president and CEO, said in a company press release.
MS results from misguided immune system attacks on the myelin sheath that protects nerve cell fibers, damaging the cells’ ability to communicate via electrical signals.
Impaired signaling leads to a range of disease symptoms, particularly problems with movement that affect walking.
Fampyra is an extended-release tablet that works to improve the conduction of electric signals in damaged nerve cells, correcting some of the difficulties brought by MS-related inflammation. It is known to block the activity of potassium channels — specialized proteins in nerve cells that control the flow of potassium ions — a critical step for cells in sending electrical impulses.
The treatment’s U.S. approval in 2010 was based on data from two Phase 3 clinical trials (NCT00127530 and NCT00483652) that collectively enrolled 540 people with MS-related walking difficulties in the U.S. and Canada. Both trials showed that short-term treatment (nine to 14 weeks) improved patients’ walking speed compared with a placebo.
In Europe, a Phase 3 trial called ENHANCE (NCT02219932) in 646 MS patients with moderate to severe disability supported Fampyra’s standard approval by the European Medicines Agency in 2017, following initial conditional approval given in 2011.
Trial results showed that six months of treatment significantly improved patients’ walking and mobility relative to a placebo.
The agreement between Acorda and Biogen was established in 2009. Acorda will now work with regulatory authorities outside the U.S. in the transfer of marketing authorizations for Fampyra, and finalize arrangements to distribute the medication in each country.
“We are grateful to Biogen for their partnership over the last 14 years, and for their commitment to collaborating with us during this transition,” Cohen said.
About the Author
