Merck Intends to Submit Cladribine Tablets to Treat Multiple Sclerosis for Registration in Europe

Decision based on data available from the Cladribine Tablets clinical program and performed analyses

14-Sep-2015 - Germany

Merck 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 aletter of intentto 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.

Merck wound down its clinical development program for Cladribine Tablets in 2011 after some regulatory authorities expressed concerns over the insufficient characterization 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.

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