181 0 Kommentare Acorda Therapeutics to Regain Global Commercialization Rights to FAMPYRA by January 2025

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced it will regain global commercialization rights to FAMPYRA (fampridine) following a decision by Biogen to terminate the license and collaboration agreement between the companies, effective January 1, 2025. FAMPYRA is indicated in the European Union and other territories throughout the world for the improvement of walking in adults with multiple sclerosis (MS) with walking disability. Acorda markets the medication as AMPYRA (dalfampridine) in the United States.

Acorda and Biogen are working together toward a transition for Acorda to commercialize and supply FAMPYRA for the great majority of people with MS outside the United States currently being served. Acorda plans to assume commercialization responsibilities as soon as possible during 2024 as marketing authorization transfers and distribution arrangements are finalized for each territory.

“We are excited to bring FAMPYRA in-house, which we believe will add significant value to Acorda, and allow us to continue to provide access to this important medication for people with MS around the world,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “We are grateful to Biogen for their partnership over the last 14 years, and for their commitment to collaborating with us during this transition.”

About FAMPYRA

FAMPYRA is a prolonged-release (sustained release) tablet formulation of the drug fampridine (4-aminopyridine, 4-AP or dalfampridine). FAMPYRA is indicated in the European Union for the improvement of walking in adult patients with multiple sclerosis (MS) with walking disability (EDSS 4-7). In clinical trials the highest incidence of adverse reactions identified with FAMPYRA given at the recommended dose was urinary tract infection. Other adverse drug reactions identified were mainly divided between neurological disorders such as insomnia, balance disorder, dizziness, paraesthesia, and headache, and gastrointestinal disorders including nausea, dyspepsia and constipation. In post-marketing experience, there have been reports of seizure. Please see FAMPYRA EPAR for more information.

About AMPYRA

AMPYRA is an extended release tablet formulation of dalfampridine (4-aminopyridine, 4-AP or fampridine). AMPYRA is a potassium channel blocker approved as a treatment to help improve walking in adults with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. Please see the AMPYRA Patient Medication Guide for more information.

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