Decision based on most recent data available from the Cladribine tablets clinical programme and newly performed analyses
Merck 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. The company 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. Its 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, 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 optimising their care, and to achieve this we need to have access to more thera