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 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 characterisation of the benefit-risk profile of Cladribine, and this has driven our decision to move forward with the registration process,” said Belén Garijo, Member of the Executive Board of Merck and CEO Healthcare.
Merck wound down its clinical development programme for Cladribine tablets in 2011 after some regulatory authorities expressed concerns over the insufficient characterisation of the drug’s benefit-risk profile. Nevertheless, several large clinical trials were allowed to complete and additional safety information was also collected in a long-term registry.