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
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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