FDA approves Acorda’s MS drug (NASDAQ:ACOR)

It was a bad news for Acorda Therapeutics when they heard the news that NASDAQ has halted their trading and shares of Acorda Therapeutics were 18 percent down on the stock market. It was on Wednesday that FDA was going to provide their review about the investigational multiple sclerosis drug Fampridine also known as Amaya developed by Acorda Therapeutics. But the bad news was short-lived as the Food and Drug Administration’s Peripheral and Central Nervous System Drugs Advisory Committee voted in the favor of Fampridine-SR. The advisory panel voted 12 to 1 in favor of Fampridine that it improves the walking ability of patients suffering from multiple sclerosis.

The FDA panel said that the clinical data for Fampridine-SR demonstrated substantial evidence of effectiveness as a treatment to improve walking in people with MS and also voted that it is clinically meaningful and is safe for medical use. However, Fampridine has been associated with risk of seizures at higher doses than the 10 mg for which Acorda Therapeutics has proposed a Risk Evaluation &Mitigation Strategy (REMS) program which would include healthcare professionals and patient education for appropriate use of Fampridine-SR. However, FDA panel did indicate that the reason behind approval of Fampridine is because large number of patients showed improvement in their walking once they were on Fampridine-SR.