SERONO'S MS TREATMENT GRANTED FAST-TRACK STATUS

Serono International has announced that its oral cladribine product has been granted fast-track status by the FDA. This designation covers the indication for relapsing forms of multiple sclerosis (MS).

Serono's proprietary oral formulation of cladribine is currently being evaluated in a multicenter, multnational Phase III study, CLARITY. It is a two-year, double-blind, placebo-controlled study involving more than 1,200 patients. Patient enrollment is expected to be completed by the end of the year.

Fast-track designation is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. The drug is eligible for priority review, and the FDA may consider for review portions of the marketing application before the new drug application is completed.

Cladribine is 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. Through its differentiated mechanism of action, oral cladribine may offer an alternative option to patients with multiple sclerosis.