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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 approval for short-course therapy with Cladribine Tablets, moving us one step closer to meeting an unmet need as an oral, disease-modifying drug available for relapsing MS,” said Fereydoun Firouz, president and chief executive officer of EMD Serono. “Our commitment to people living with MS is to transform the way they approach their therapy options, and Priority Review for short-course therapy with Cladribine Tablets means we are moving closer to delivering on this promise. We look forward to working with the FDA throughout the regulatory process.”

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