EMD Serono’s Mavenclad (Cladribine) Receives FDA’s Approval for RRMS and SPMS in Adults

EMD Serono’s Mavenclad (Cladribine) Receives FDA’s Approval for RRMS and SPMS in Adults

Shots:

  • The approval is based on P-III CLARITY study assessing Mavenclad vs PBO in 1,976 patients with RRMS and SPMS in adults
  • P-III CLARITY study results: 58% reduction in the ARR; free of relapses after two years of short-course oral treatment (81% vs 63%); @3mos. reduction in risk of confirmed disability progression 33%, lower median number of T1-weighted gadolinium-enhanced brain lesions and new or enlarging T2 brain lesions (0, 0 vs 0.33, 0.67)
  • Mavenclad is a short-course oral therapy with proven two years of efficacy having max. 20 days of treatment in adults with RRMS and SPMS and is approved in 50 countries, including the EU, Canada, Australia and Switzerland, for various relapsing MS indications

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