11 September 2015 -Merck, a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials today announced that it intends to submit its investigational treatment Cladribine tablets for the treatment of relapsing multiple sclerosis for registration in Europe. The decision follows the company’s evaluation of new data and additional analyses of the compound’s benefit-risk profile.

Merck has submitted a letter of intent to the EMA to file a Marketing Authorization Application (MAA) for Cladribine tablets, which initiates a process to address a number of pre-submission requirements. The company’s submission plan for other geographies is being further developed and executed.

“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 Professor Giancarlo Comi, director of the Institute of Experimental Neurology (INSPE) and of the department of neurology at San Raffaele Hospital in Milan, Italy. “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."

For more details, go to: http://www.merckgroup.com/en/media/extNewsDetail.html?newsId=1C517A71C016A43BC1257EBC006B50C3&newsType=1