ROCKLAND, Mass., July 28 /PRNewswire/ — 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(1) 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(2) in February
(1) CLARITY: CLAdRIbine Tablets Treating MS OrallY
(2) Giovannoni G et al. A place