Source:Merck KGaA

Merck KGaA recently announced the submission of a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Cladribine Tablets, Merck’s proprietary investigational oral formulation of cladribine, as a therapy for patients with relapsing-remitting multiple sclerosis (MS). Cladribine Tablets could become the first orally administered disease-modifying therapy available for patients with MS, as all disease-modifying therapies currently approved for the treatment of MS are injectable.

“The submission of Cladribine Tablets to the EMEA brings us closer to the possibility of providing an oral short-course treatment to patients with multiple sclerosis and underscores our commitment to provide new options for the management of relapsing-remitting multiple sclerosis,” said Roberto Gradnik, Executive Vice President Commercial Europe of the division Merck Serono. “We look forward to working with the EMEA and the European member states’ authorities.”

The MAA submission is supported by results from the CLARITYa study, a two-year, randomized, double-blind, placebo-controlled Phase III trial of Cladribine Tablets in patients with relapsing-remitting MS. The CLARITY data were presented at the 61st Annual Meeting of the American Academy of Neurology (AAN) in April 2009 and at the 19th Meeting of the European Neurological Society (ENS) in June 2009.

Merck is currently submitting new drug applications for Cladribine Tablets in several other countries, including the United States in the current quarter.

In Other News: Merck Reports Oral MS Drug Effective

This entry was posted on Thursday, July 23rd, 2009 at 7:43 am and is filed under News Alerts. You can follow any responses to this entry through the RSS 2.0 feed.