Merck Submits Application for Cladribine Tablets as a Multiple Sclerosis Therapy in the United States
Merck KGaA announced the submission of a New Drug Application (NDA) to the US food and Drug Administration (FDA) for Cladribine Tablets, Merck’s proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). Cladribine Tablets has the potential to be the first orally administered diseasemodifying therapy available for people living with relapsing MS, as all diseasemodifying therapies currently approved for the treatment of MS are parenteral therapies.
The NDA submission is supported by results from the CLARITY a study, a two-year, randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in people with relapsing-remitting MS. The NDA also shows that all primary and secondary endpoints of the CLARITY trial were met. The CLARITY data were presented at the 61st Annual Meeting of the American Academy of Neurology (AAN) in April 2009 and at other recent international scientific meetings.
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