ZUG, Switzerland Biogen Idec hopes to win approval for a multiple sclerosis drug in Canada and the European Union with regulatory approval applications that it recently submitted, the Swiss drug maker announced Tuesday.
The drug maker filed a marketing authorization application with the European Medicines Agency and a new drug submission application with Health Canada for Fampridine-PR (fampridine prolonged-release tablets), designed to improve walking ability in adult MS patients. The Food and Drug Administration also recently accepted an approval application for the drug, which Acorda Therapeutics plans to market under the Fampridine-SR brand; the Canadian version also will be marketed as Fampridine-SR.
“Walking impairment has a significant impact on the lives of many people living with MS,” Biogen Idec SVP neurology research and development Alfred Sandrock said in a statement. “Fampridine-PR tablets may offer a novel approach to address this debilitating aspect of the disease by improving the walking ability of MS patients.”