Merck Serono has submitted a new drug application to the US Food and Drug Administration (FDA) for cladribine tablets, a new oral treatment to reduce relapses in people with relapsing forms of multiple sclerosis (MS).

Merck Serono’s proprietary investigational oral formulation of cladribine has the potential to become the first orally administered disease-modifying therapy available for people living with relapsing MS.

Merck Serono’s US subsidiary EMD Serono president and CEO Fereydoun Firouz said the new treatment would meet an unmet need as an oral disease-modifying drug.

“If approved, short-course therapy with cladribine tablets could transform the way people approach their treatment options,” Firouz said.

The application is supported by results from the Clarity(a) study, which met all primary and secondary endpoints during a two-year, randomised, double-blind, placebo-controlled Phase III trial.

Merck Serono also submitted a marketing authorisation application to the European Medicines Agency (EMEA) for cladribine tablets in July 2009.