Merck Serono Submits Cladribine for European Authorisation

23 July 2009 (Last Updated July 23rd, 2009 18:30)

Merck has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMEA) for cladribine, an oral treatment for relapsing-remitting multiple sclerosis (MS). The submission is based on successful results from the two-year CLARITYa study, a randomised, double-

Merck has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMEA) for cladribine, an oral treatment for relapsing-remitting multiple sclerosis (MS).

The submission is based on successful results from the two-year CLARITYa study, a randomised, double-blind, placebo-controlled Phase III trial of cladribine tablets in patients with the disease.

Merck Serono executive vice-president of commercial Europe Roberto Gradnik said that the submission of cladribine tablets to the EMEA brings the company closer to the possibility of providing an oral short-course treatment to patients with multiple sclerosis.

Merck will also be submitting new drug applications for cladribine tablets in several other countries, including the US.