The US Food and Drug Administration (FDA) has given its backing to Acorda Therapeutics' Fampridine-SR, a new treatment to improve walking in people with multiple sclerosis (MS).
The FDA's Peripheral and Central Nervous System Drugs (PCNSD) Advisory Committee voted 12 to one that clinical data on Fampridine-SR 10mg twice daily demonstrated substantial effectiveness and voted ten to two that it is clinically meaningful and can be safe for use.
Acorda Therapeutics president and CEO Ron Cohen said that [eople with MS have an urgent need for therapies to improve their walking, which is essential to conducting their activities of daily life.
"If approved, Fampridine-SR would be the first medicine to improve walking in people with MS," Cohen said.
In laboratory studies, Fampridine has been found to improve impulse conduction in nerve fibres in which the myelin insulating layer has been damaged.
The Committee also recommended by a vote of 12 to one that Acorda evaluate the effects of doses lower than 10mg twice daily, but that this would not be required prior to approval.
The FDA is set to complete its review of Fampridine-SR by 22 October 2009.