US FDA clears Elan/Acorda's Ampyra to improve walking in adults with multiple sclerosis

25 January 2010

The USA's Food and Drug Administration has approved Ampyra (dalfampridine; previously referred to as Fampridine-SR) extended release tablets to improve walking in patients with multiple sclerosis (MS). In clinical trials, patients treated with Ampyra had faster walking speeds than those treated with an inactive pill (placebo).

This is the first drug approved for this use, and is also the first new therapy for MS cleared by the FDA since 2004. Ampyra is made by Ireland-headquartered Elan and will be distribute by Acorda Therapeutics in the USA, under an agreement announced in early 1997, whereby Elan granted to Acorda exclusive, worldwide rights to develop and market fampridine for spinal cord injury. In addition, Elan took an equity stake in Acorda. The news saw Acorda's stock price jump nearly 10% to $28.12 by close of trading on January 22, in volume of over 6 million shares compared with a daily average of 429,000, reported TheStreet.com.

Global sales potential of $1 billion a year

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