FDA Approves Genentech’s OCREVUS™ (Ocrelizumab) for Relapsing and Primary Progressive Forms of Multiple Sclerosis
Ocrevus will be available by mid-April.
Key data in RMS patients treated with OCREVUS showed:
A 46 percent and 47 percent relative reduction in the annualized relapse rate (ARR) compared with interferon beta-1a over the two-year period in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
A 40 percent relative risk reduction in confirmed disability progression (CDP) sustained for 12 weeks compared with interferon beta-1a in a pooled analysis of OPERA I and OPERA II, as measured by the Expanded Disability Status Scale (EDSS) (p=0.0006).
A 94 percent and 95 percent relative reduction in the total number of T1 gadolinium-enhancing lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
A 77 percent and 83 percent relative reduction in the total number of new and/or enlarging T2 lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
Key data in PPMS patients treated with OCREVUS showed:
A 24 percent relative risk reduction in CDP sustained for at least 12 weeks compared with placebo, as measured by the EDSS (p=0.0321).
A -0.39 cm3 mean change in volume of brain hyperintense T2 lesions compared with a 0.79 cm3 mean change in volume of placebo-treated patients over 120 weeks (p<0.0001).
A 25 percent relative risk reduction in the proportion of patients with 20 percent worsening of the timed 25-foot walk confirmed at 12 weeks.
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Ocrevus will be available by mid-April.
Key data in RMS patients treated with OCREVUS showed:
A 46 percent and 47 percent relative reduction in the annualized relapse rate (ARR) compared with interferon beta-1a over the two-year period in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
A 40 percent relative risk reduction in confirmed disability progression (CDP) sustained for 12 weeks compared with interferon beta-1a in a pooled analysis of OPERA I and OPERA II, as measured by the Expanded Disability Status Scale (EDSS) (p=0.0006).
A 94 percent and 95 percent relative reduction in the total number of T1 gadolinium-enhancing lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
A 77 percent and 83 percent relative reduction in the total number of new and/or enlarging T2 lesions compared with interferon beta-1a in OPERA I and OPERA II, respectively (p<0.0001 and p<0.0001).
Key data in PPMS patients treated with OCREVUS showed:
A 24 percent relative risk reduction in CDP sustained for at least 12 weeks compared with placebo, as measured by the EDSS (p=0.0321).
A -0.39 cm3 mean change in volume of brain hyperintense T2 lesions compared with a 0.79 cm3 mean change in volume of placebo-treated patients over 120 weeks (p<0.0001).
A 25 percent relative risk reduction in the proportion of patients with 20 percent worsening of the timed 25-foot walk confirmed at 12 weeks.
http://www.businesswire.com/news/hom...apsing-Primary
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