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Wednesday, September 4, 2019

Genentech to Present Pivotal Data for Satralizumab in Neuromyelitis Optica Spectrum Disorder and Six-year Ocrevus (Ocrelizumab) Data in Multiple Sclerosis at ECTRIMS

Published: Sep 04, 2019

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Sept. 4, 2019 05:00 UTC
  • Investigational medicine satralizumab significantly reduces the risk of relapse in pivotal SAkuraStar monotherapy study for neuromyelitis optica spectrum disorder (NMOSD)
  • New data provide insights into neurofilament light chain (NfL) levels as a potential biomarker for predicting multiple sclerosis (MS) disability progression; new longer-term Ocrevus data of more than six years show reduction of disability progression in relapsing and primary progressive MS
  • Breadth of data reinforce Genentech's commitment to following the science to gain a better understanding of complex nervous system disorders
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data across its neuroscience portfolio will be presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) from September 11-13 in Stockholm. Presentations include complete Phase III results from the SAkuraStar study investigating satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD), and new multiple sclerosis (MS) research, which provides insights into disease progression, including data from Ocrevus®(ocrelizumab) trials that advance understanding of neurofilament light chain (NfL) levels as a potential biomarker for predicting disability outcomes. Additionally, longer-term data of more than six years to be presented continue to show consistent safety and efficacy outcomes for patients treated with Ocrevus earlier.
“Disorders of the nervous system are some of the most complex and difficult to treat, and we have increased our commitment in neuroscience to advance care and scientific understanding for conditions such as multiple sclerosis and neuromyelitis optica spectrum disorder. Data being presented at ECTRIMS include positive Phase III results for satralizumab as a monotherapy, taking a novel approach to treating neuromyelitis optica spectrum disorder, and new insights using biomarkers to identify disease progression in multiple sclerosis,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Similar to our approach with Ocrevus in multiple sclerosis, targeting B cells as a key driver of disease, we aim to offer satralizumab as a highly effective treatment option in neuromyelitis optica spectrum disorder, targeting the interleukin-6 receptor.”
About neuromyelitis optica spectrum disorder (NMOSD)
Complete pivotal data from the SAkuraStar study investigating satralizumab as a subcutaneous monotherapy compared to placebo for the treatment of NMOSD will be presented. The primary and subgroup analyses show that satralizumab significantly reduces the risk of relapse in patients who were seropositive for aquaporin-4 auto-antibodies (AQP4-IgG), as well as the overall intention-to-treat (ITT) population representative of NMOSD patients. Satralizumab also demonstrates a similar safety profile compared to placebo.
NMOSD is a rare, lifelong and debilitating autoimmune disease of the central nervous system commonly misdiagnosed as MS. It is associated with pathogenic AQP4-IgG auto-antibodies that target and damage a specific cell type, called astrocytes, resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain. Through the use of a diagnostic biomarker test, the majority of people with NMOSD are identified as AQP4-IgG seropositive and tend to experience a more severe disease course; however, as many as one-third of those with NMOSD are AQP4-IgG seronegative. At ECTRIMS, two analyses of U.S. healthcare insurance claims databases will be presented that reflect the low utilization of AQP4-IgG diagnostic testing and the subsequent frequency of misdiagnosis of NMOSD patients.
Additionally, two pre-clinical in-vitro models will be presented that show satralizumab reduces the degradation of the blood brain barrier, supporting evidence of its multi-faceted mechanism of action.

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