EMA Accepts MAA For Merck KGaA’s MS DrugBy
The European Medicines Agency (EMA) has accepted for review Merck KGaA’s marketing authorization application (MAA) for the investigational product, cladribine tablets for treating relapsing-remitting multiple sclerosis (MS).
Cladribine is an oral small-molecule prodrug that selectively and periodically targets lymphocytes thought to be integral to the pathological process of MS. Cladribine is currently under clinical investigation and not approved for any use in the United States, Canada and Europe.
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