EMD Serono, Inc., an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS).
The application also has been granted a Priority Review designation by the FDA, which means the review period for the NDA is reduced. The goal for completing a Priority Review is six months instead of the standard 10 months. Priority Review is applied to drugs that have the potential to provide significant advances in treatment. A decision by the FDA is expected in Q4 2010.
"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 CEO of EMD Serono, Inc. "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."
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. The CLARITY study results were published in The New England Journal of Medicine in February 2010.
SOURCE EMD Serono, Inc.