If successful, oral cladribine will be the first oral therapy for multiple sclerosis with the convenience of short courses of therapy with intermittent administration.
The study will provide data on key endpoints including clinical relapses, disability progression and magnetic resonance imaging (MRI). Study participants have been enrolled in one of the three arms of the study to receive one of two different dose regimens of oral cladribine or matching placebo tablets.
Oral cladribine was designated a fast track product by the FDA in September 2006. Under fast track designation, oral cladribine is eligible for priority review and the FDA may consider portions of the marketing application for review before the new drug application is completed.