FDA Gives Priority Review Status to Application for Oral Cladribine to Treat Relapsing Multiple Sclerosis
EMD Serono has announced that the U.S. Food and Drug Administration has accepted and given Priority Review to its application seeking approval to market cladribine as an oral disease-modifying therapy for relapsing forms of MS. A Priority Review means that the FDA will review the drug in less than the usual amount of time. This designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The goal for completing a Priority Review is six months from when the application is submitted, meaning that the agency’s approval decision could happen in December 2010, but it might take longer.
In a large-scale phase 3 clinical trial, cladribine tablets significantly reduced relapse rates and other disease activity in people with relapsing-remitting MS. Read more about this study.
In November 2009, EMD Serono announced that it had received a “refuse to file” letter from the FDA for its original cladribine application submitted in late September, which usually means that the agency deems the application incomplete. On June 8, 2010, EMD Serono announced that it resubmitted its application to the FDA for approval of cladribine.
Another oral therapy for MS, fingolimod (Novartis International AG), is currently undergoing final review by the FDA after an FDA advisory committee recommended that it be approved. The agency’s approval decision for fingolimod is expected in September 2010.