Breaking News, Trials & Filings

EMD Serono’s Cladribine Tablets Get Priority Review

EMD Serono’s NDA for Cladribine Tablets has accepted for filing as a therapy for relapsing forms of multiple sclerosis (MS).

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By: Tim Wright

Editor-in-Chief, Contract Pharma

EMD Serono’s NDA for Cladribine Tablets has accepted for filing as a therapy for relapsing forms of multiple sclerosis (MS). The application also has been granted a Priority Review designation by the FDA and a decision is expected in 4Q10. The NDA is supported by results from the CLARITY study, a two-year, randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in people with relapsing-remitting MS. “This is a critical milestone on the path to potential ap...

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