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Tuesday, September 15, 2015

Merck Prepares to File for European Marketing Authorization for Cladribine Tablets as a Multiple Sclerosis Therapy

September 14, 2015

Merck recently reported its intention to file for European registration of its product candidate for relapsing multiple sclerosis – Cladribine, a synthetic anti-cancer agent able to suppress the immune system. Cladribine causes relatively few side effects and results in very little non-target cell loss. Merck’s decision follows new findings and further characterization of the compound’s benefit-risk profile.
The company has already sent a letter of intent to the European Medicines Agency (EMA) to file a Marketing Authorization Application (MAA) for Cladribine Tablets, for which Merck has been issued a list of pre-submission requirements. The company is simultaneously pursuing regulatory milestones in other territories across the globe.
“I applaud Merck for its decision to move forward with Cladribine Tablets as demonstrated in its Letter of Intent to the European Medicines Agency,” said the Director of the Institute of Experimental Neurology (INSPE) and of the department of neurology at San Raffaele Hospital in Milan, Italy, Professor Giancarlo Comi in a news release. “This decision is very positive for patients with multiple sclerosis because tailoring treatment to their individual needs is a key strategy for optimizing their care, and to achieve this we need to have access to more therapeutic options. While the options available to treating neurologists have grown over the years, Cladribine Tablets have the potential to offer a truly innovative addition to the armamentarium physicians have at their disposal to treat their patients.”
“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,” said the CEO Healthcare and Member of the Executive Board of Merck, BelĂ©n Garijo.


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