Merck intends to file for European approval of cladribine tablets in MS

11 September 2015

German pharma company Merck KGaA (MRK: DE) has stated its intention to apply for marketing authorization in Europe for cladribine tablets in multiple sclerosis.

This decision follows the company’s evaluation of new data from the clinical program studying the drug in relapsing multiple sclerosis. Merck wound down its clinical development of Cladribine tablets in 2011 after some regulatory authorities expressed concerns over it. Despite this, several large clinical trials were allowed to complete and additional safety information was also collected in a long-term registry.

Belén Garijo, chief executive of healthcare at Merck, said: “Time has brought additional data that allow a better characterization of the benefit-risk profile of cladribine, and this has driven our decision to move forward with the registration process."

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