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

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 intentbto 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, Belén Garijo.

In 2011, Merck’s development program for Cladribine Tablets was met with opposition after several regulatory authorities noted a lack of detailed characterization on the drug’s benefit-risk profile. Since then, a number of large-scale clinical trials were brought to completion and supplemental safety information was also obtained in a long-term registry.

About Multiple Sclerosis

Multiple sclerosis is a chronic condition, characterized by an inflammatory state that affects the central nervous system. It is considered the most common, disabling, non-traumatic neurological disorder in young adults. Around two million individuals worldwide are estimated to suffer from MS . The most common symptoms of the disease include tingling or numbness in the limbs, lack of coordination and strength, and blurred vision. Relapsing multiple sclerosis is the most common form of the disease.

In a newly published study in the PLOS One journal entitled “Reliability of Intra-Retinal Layer Thickness Estimates“, researchers from Germany explored the precision and reliability of a medical imaging technique named optical coherence tomography (OCT) in measurements of thickness of different intra-retinal layers in patients with multiple sclerosis (MS). This parameter has been considered a good indicator to monitor neurological conditions.