Serono (NYSE: SRA)’s oral cladribine has been granted Fast Track Status by the USFDA for the treatment of patients with relapsing forms of multiple sclerosis.
The novel oral formulation of cladribine for the treatment of MS is currently being investigated in a multi-center, multi-national Phase III study, a two-year, double-blind, placebo-controlled study involving over 1,200 patients: CLARITY (CLAdRIbine Tablets Treating MS OrallY).
According to Ernesto Bertarelli, CEO of Serono:
"We are very pleased that oral cladribine has been designated a Fast Track product. As a leader in multiple sclerosis, we are committed to providing new treatment options that can further improve the quality of the lives of people with this serious disease and our objective is to bring to them the first oral disease modifying treatment."
While injectable drugs are currently available for the treatment of some forms of multiple sclerosis, there is a need for better alternatives which oral cladribine, a purine nucleoside analogue that interferes with the behavior and the proliferation of certain white blood cells, particularly lymphocytes (which are involved in the pathological process of multiple sclerosis), can offer.
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