Merck Submits NDA For Cladribine Tablets In US

Germany-based Merck has submitted a new drug application (NDA) to the FDA for Cladribine tablets, an investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS).

The NDA submission is supported by results from the CLARITY study, a two-year, randomised, double-blind, placebo-controlled phase III trial of Cladribine tablets in people with relapsing-remitting MS.

Fereydoun Firouz, president and CEO of EMD Serono, said: “We continue to focus on making a positive difference in the lives of people living with MS, and their families. If approved, short-course therapy with Cladribine Tablets could transform the way people approach their treatment options, and meet an unmet need as an oral, disease-modifying drug available for MS. We look forward to working with the FDA during the course of the regulatory process.”

Reportedly, Merck Serono submitted a marketing authorization application to the European Medicines Agency (EMEA) for Cladribine Tablets in July 2009.