Genentech to Present Pivotal Data for Satralizumab in Neuromyelitis Optica Spectrum Disorder
South San Francisco, CA -- September 3, 2019 -- 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).
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.
About Satralizumab
Satralizumab is an investigational humanized monoclonal antibody that represents a novel approach to treating NMOSD. The cytokine IL-6 is thought to be a key driver of NMOSD, triggering the inflammation cascade and leading to damage and disability. Positive Phase III results for satralizumab, as both monotherapy and add-on to baseline immunosuppressant therapy, suggest that IL-6 inhibition may be an effective therapeutic approach for NMOSD.
The Phase III clinical development program for satralizumab includes two studies: SAkuraSky, which studied satralizumab in combination with baseline immunosuppressant therapy, and SAkuraStar, which studied the efficacy and safety of satralizumab as a monotherapy.
Satralizumab has been designated as an orphan drug in the United States and Europe. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMO and NMOSD by the U.S. Food and Drug Administration in December 2018.
About Genentech in Neuroscience
Neuroscience is a major focus of research and development at Genentech and Roche. The company’s goal is to develop treatment options based on the biology of the nervous system to help improve the lives of people with chronic and potentially devastating diseases. Genentech and Roche have more than a dozen investigational medicines in clinical development for diseases that include multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism.
About Genentech
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com/.
Source: Genentech
Posted: September 2019
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