Tag Archives: Multiple Sclerosis
Merck KGaA MS Drug on the Fast Track
Merck KGaA received word July 25 that its application for the multiple sclerosis treatment Cladribine had received priority review status by FDA, decreasing the evaluation period from 10 months to six months, and closing the gap between Merck and the competition.
“This is a critical milestone on the path to potential approval for short-course therapy with [...]
Posted in Strategy Also tagged Cladribine, EMD Serono, Fereydoun Firouz, Food and Drug Administration, Gilenia, Merck KGaA, Merck Serono, Novartis Leave a comment
Acorda Seeking NDA for MS Drug
Hawthorne, NY-based Acorda Therapeutics yesterday released Phase III clinical trial data of fampridine-SR, a novel treatment that improves walking ability in Multiple Sclerosis patients.
Acorda filed a New Drug Application for fampridine on January 30, and FDA approval is expected in about 10 months. If green-lighted, fampridine will be the first drug approved with the indication [...]

Is Sanofi Right to Bank on MS Drug?