Acorda drug eligible for coordinated review in Europe
Acorda Therapeutics Inc. said that its new multiple sclerosis drug is eligible for a centralized regulatory review in Europe, potentially opening up huge new markets for the medication if it receives approval.
The Hawthorne-based biotech company has been seeking approvals for the drug, known as Fampridine-SR, after a study showed that patients taking the medication walked faster than patients taking a placebo.
Multiple sclerosis is a chronic nervous-system disease in which the immune system attacks nerve fibers in the brain and spinal cord. If the drug is approved, the drug could one day make walking easier for the multiple sclerosis victims who deal with mobility problems.
Acorda said that European regulators have decided that the drug can be evaluated in a single, coordinated review on behalf of all European Union member countries, instead of the time consuming process of each country doing the evaluation seperately. Acorda could gain a 10-year market exclusivity for Fampridine-SR in European Union countries under the approval process.
Acorda is also seeking approval to market the drug in the United States from the U.S. Food and Drug Administration.