Merck KGaA Plans EU Filing for MS Drug
Merck KGaA plans to submit its investigational treatment, cladribine tablets, for treating 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 KGaA has submitted a letter of intent to the European Medicines Agency 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 KGaA wound down its clinical development program for cladribine 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 be completed, and additional safety information was also collected in a long-term registry.
Source: Merck KGaA