Wednesday, Apr 7, 2021
Evrysdi (risdiplam) 2-year FIREFISH Part 2 data show improvement in motor function in infants with Type 1 spinal muscular atrophy (SMA)
Ocrevus (ocrelizumab) data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS)
Data for Enspryng (satralizumab-mwge) in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs)
Data for investigational MS medicine fenebrutinib support its safety profile and high potency
Additional presentations on investigational programs, including Alzheimer’s disease and Huntington’s disease, help advance scientific understanding of neurological disorders
South San Francisco, CA — April 7, 2021 —
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data for its approved and investigational medicines for the treatment of neurological disorders will be presented at the 73rd American Academy of Neurology (AAN) Annual Meeting being held virtually April 17-22, 2021. These new data include 23 abstracts highlighting the expanding Genentech neuroscience portfolio across six therapeutic areas, including Evrysdi™ (risdiplam) for spinal muscular atrophy (SMA), Ocrevus® (ocrelizumab) in relapsing and primary progressive multiple sclerosis (RMS and PPMS), investigational Bruton’s tyrosine kinase inhibitor (BTKi) fenebrutinib in Phase III trials for RMS and PPMS, Enspryng™ (satralizumab-mwge) in neuromyelitis optica spectrum disorder (NMOSD), and data from investigational programs in Alzheimer’s disease (AD) and Huntington’s disease (HD).
“Following U.S. FDA and global approvals for our groundbreaking therapies in SMA and NMOSD, Roche and Genentech’s data at AAN reflect our continued commitment to meaningful therapeutic progress for people living with neurological disorders,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We are proud to collaborate with patient advocates, academia, industry and the broader healthcare community through cutting-edge research and partnerships to advance the scientific understanding of neurological conditions, which have historically been among the hardest disorders to study, diagnose and treat.”
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Multiple Sclerosis (MS)Genentech will present data from its MS franchise, including five presentations covering Ocrevus and results from studies on the investigational BTKi fenebrutinib. Real-world data continue to show the highest persistence and adherence to Ocrevus, the only MS therapy with a twice-yearly dosing schedule, over one year compared to other disease-modifying therapies (DMTs). Additionally, a post-hoc analysis of the ORATORIO Phase III PPMS study will be presented, which suggests Ocrevus significantly slowed atrophied T2-lesion volume accumulation, a subclinical measure of disease progression. Furthermore, interim analysis of the open-label Phase IIIb ENSEMBLE study shows Ocrevus treatment provided consistent benefit over one year in patients who were recently diagnosed with relapsing-remitting multiple sclerosis (RRMS) and had not received prior DMT.
Genentech is continuing to advance the science in MS and is exploring the investigational medicine fenebrutinib. Data from fenebrutinib, a highly selective, non-covalent, reversible oral BTKi, support its safety profile in several autoimmune diseases and high potency, which is encouraging for the ongoing Phase III studies in RMS and PPMS. Fenebrutinib is a dual inhibitor of both B-cell and myeloid lineage-cell activation, which may offer a novel approach to slowing disease progression by targeting both acute and chronic inflammatory aspects of MS.
Neuromyelitis Optica Spectrum Disorder (NMOSD)Genentech will present five sets of data on adults living with NMOSD. Data from the Phase III SAkuraStar and SAkuraSky clinical trials reinforce the favorable safety and efficacy of this therapy for those living with NMOSD, including patients with concomitant autoimmune diseases (CAIDs).
New longitudinal, observational data from the CIRCLES study, conducted in collaboration with the Guthy-Jackson Charitable Foundation, a patient advocacy organization dedicated to funding research on NMOSD epidemiology, pathogenesis and treatment, also will be presented. The CIRCLES study explored factors that influence treatment change in people living with NMOSD, including those who have experienced only one relapse.
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