Biogen Idec Issues Statement On U.S. Approval Of AMPYRA™ (dalfampridine)

Main Category: Multiple Sclerosis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 25 Jan 2010 - 3:00 PDT

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Biogen Idec (NASDAQ: BIIB) today issued the following statement regarding the United States (U.S.) Food and Drug Administration (FDA) approval of AMPYRA™ (dalfampridine) to improve walking in patients with multiple sclerosis (MS). This was demonstrated by an increase in walking speed. The U.S. FDA approval was granted on January 22, 2010.

AMPYRA will be marketed in the U.S by Acorda Therapeutics, Inc. (NASDAQ: ACOR). AMPYRA is an extended release tablet formulation of the investigational drug dalfampridine (4-aminopyridine and called fampridine outside the U.S.). Biogen Idec will commercialize fampridine as a prolonged release tablet in markets outside of the U.S.

"For people with MS, impaired walking ability is one of the most common and concerning aspects of the disease," said Alfred Sandrock, MD, PhD, senior vice president, Neurology Research and Development, Biogen Idec. "AMPYRA may be an important therapy in reducing the impact of this debilitating condition."

"We congratulate our partner, Acorda Therapeutics, on this important achievement and look forward to working with regulators outside of the U.S. to make this therapy available to all people living with MS."

On 12 January 2010, Biogen Idec announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency for prolonged release fampridine tablets for the improvement of walking ability in adult patients with multiple sclerosis (MS). The company also has filed a New Drug Submission (NDS) to Health Canada.

About AMPYRA

AMPYRA is an extended release tablet formulation of the investigational drug fampridine (4-aminopyridine or 4-AP). Extended release fampridine tablets act by blocking the potassium channels in demyelinated nerves, which reduces the leakage of current from the axons, restoring neuronal conduction, and action potential formation.

This tablet formulation was developed and commercialized in the U.S. by Acorda Therapeutics. Biogen Idec will commercialize fampridine as prolonged release tablets in markets outside of the U.S.

Source
Biogen Idec

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