Merck finally gains US approval of Mavenclad

The US Food and Drug Administration has finally given its approval for Mavenclad (cladribine), in the all important American market, for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive disease (SPMS).

German drugmaker Merck KGaA’s (MRK: DE) Mavenclad is the first and only FDA approved treatment for RRMS and active SPMS that provides two years of proven efficacy with a maximum of 20 days of oral treatment, during a two-year period.

Merck KGaA originally submitted Mavenclad (cladribine) tablets to the FDA for review in 2011, but the company received a complete response letter (CRL) stating a need for new studies looking into the safety of the drug.