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

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

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  • 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

Click here to read full press release/ article | Ref: PRNewswire | Image: Signbox


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