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— First and only anti-CD19 B-cell depletion monotherapy for the treatment of adult patients with NMOSD and seropositive anti-aquaporin-4 immunoglobulin G-4 (AQP4-IgG) –
NMOSD is a devastating autoimmune disease that causes severe and recurrent attacks of the central nervous system that can lead to blindness, paralysis and death.
TORONTO, Jan. 16, 2024 /CNW/ – Horizon Therapeutics plc, now part of Amgen, announced that on December 15, 2023, Health Canada approved UPLIZNA® (inebilizumab for injection) as a monotherapy for the treatment of adult patients with NMOSD who are AQP4-IgG+. This rare autoimmune disease is caused by inflammation in the central nervous system, resulting in severe and recurrent attacks that can lead to permanent disability, such as vision loss and paralysis.1 An estimated 1,000 people in Canada live with the disease.2,3,4
“Today’s approval of UPLIZNA marks a significant milestone for adults living with NMOSD in Canada, bringing a new, targeted treatment option to those living with this devastating disease,” said Matt McCarthy, general manager, Canada, Horizon. “Just a single NMOSD attack can have a life-altering impact, including pain, debilitation and irreversible vision loss. We are committed to bringing new medicines to people living with rare and challenging diseases around the world, and today’s announcement is an exciting milestone in that effort.”
Health Canada has approved UPLIZNA on the effects of the pivotal N-MOmentum trial (2014-000253-36), the largest NMOSD clinical trial to date. UPLIZNA demonstrated significant relief in the threat of NMOSD crisis with only two infusions consistent with the year. after the initial loading doses. In addition, 87. 6% of patients in the AQP4-IgG group remained relapse-free within six months of treatment. 5 UPLIZNA also demonstrated an adequate protection profile.
People affected by NMOSD live with unpredictable seizures; 90% will experience repeated attacks within five years of the initial attack. 7 The damage occurs when CD19-expressing B cells (plasmablasts and some plasma cells) secrete IgG-AQP4, triggering an expanding autoimmune response. It has been shown to be effective in preventing inflammation, lesion formation, and astrocyte loss. UPLIZNA offers a unique mode of action developed specifically to deplete CD19 B cells and prevent attacks. 5,6,7
“Historically, NMOSD has been misdiagnosed as multiple sclerosis (MS), which can delay proper treatment and lead to worse outcomes, especially if treated with MS medications,” said Mark Freedman, director of the Multiple Sclerosis Research Unit, Professor of Neurology at the University. of Ottawa, Department of Medicine, Senior Scientist, Ottawa Hospital Research Institute. “We can now, as it should be, diagnose NMOSD, which is distinctly distinct from MS and deserves express treatment. UPLIZNA is a vital new treatment option that provides NMOSD physicians and patients with a proven cure, favorable protection profile, and semi-annual maintenance. dosing regimen. “
“At the Sumaira Foundation, we are excited to see new clinically proven treatments available to NMOSD patients in Canada that provide them with additional features for the treatment and management of this rare but serious disease,” said Sumaira Ahmed, an NMOSD patient. Founder and Director. Many patients have benefited from access to these treatments in the United States, Europe, and around the world. As a patient who has been living with this rare disease for ten years, I know firsthand how vital it is to have multiple remedy functions. As a leader in patient advocacy, I’ve noticed how patients can reshape the lives of other patients.
UPLIZNA was approved through the U. S. Food and Drug Administration. The U. S. Food and Drug Administration (FDA) in June 2020, the Ministry of Health, Labor and Welfare of Japan in March 2021, the European Commission (EC) in April 2022, and the Brazilian Health Regulatory Agency (ANVISA). ) in December 2022.
To learn more about UPLIZNA, see the product monograph.
About Neuromyelitis Optica Spectrum Disorder (NMOSD)
NMOSD is a unifying term for neuromyelitis optica (NMO) and related syndromes. NMOSD is a rare, severe, relapsing neuroinflammatory autoimmune disease that attacks the optic nerve, spinal cord, brain, and brainstem. 9,10 Approximately 80% of all patients with NMOSD positive for anti-AQP antibodies4. 11 AQP4-IgG primarily binds to astrocytes in the central nervous system formula and triggers an expanding immune reaction that leads to astrocyte injury and death. 12
Anti-AQP4 autoantibodies are produced by plasmablasts and plasma cells. These B-cell populations are central to NMOSD disease pathogenesis, and a large proportion of these cells express CD19.13 Depletion of these CD19+ B cells is thought to remove an important contributor to inflammation, lesion formation and astrocyte damage. Clinically, this damage presents as an NMOSD attack, which can involve the optic nerve, spinal cord and brain.12-14 Loss of vision, paralysis, loss of sensation, bladder and bowel dysfunction, nerve pain and respiratory failure can all be manifestations of the disease.15 Each NMOSD attack can lead to further cumulative damage and disability.16,17 NMOSD occurs more commonly in women and may be more common in individuals of African and Asian descent.18,19
About the horizon
Horizon, now part of Amgen, is a global biotechnology company focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives.
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Canada S. Table 17-10-0005-01 Population estimates as of July 1, by age and sex. Updated December 21, 2022. Retrieved June 14, 2023, https://www150. statcan. gc. ca/t1/tbl1/ es/tv. action?pid=1710000501
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Rensel M, Zabeti A, Mealy M et al. Efficacy and long-term protection of inebilizumab in neuromyelitis optica spectrum disorder: investigation of aquaporin four and immunoglobulin G seropositive participants who took inebilizumab for approximately four years in the N-MOmentum trial. Journal of Multiple Sclerosis. 2021: 1352four5852110four72.
Wingerchuk DM, Hogancamp WF, O’Brien PC et al. The course of neuromyelitis optica (Devic syndrome). Neurology. 1999; 53(5):1107-1114. es what I:10. 1212/wnl. 53. 5. 1107.
Contetti EC, Correale J. Neuromyelitis optica spectrum disorders: from pathophysiology to healing strategies. Journal of Neuroinflammation. 2021;18:208.
Ajmera MR, Boscoe A, Mauskopf J, Candrilli SD, Levy M. Assessment of comorbidities and use of physical care in patients with highly active neuromyelitis optica. J Neurol Sci. 2018; 384:96-103.
What is NMO? Guthyjacksonfoundation.org. www.guthyjacksonfoundation.org/neuromyelitis-optica-nmo/ Accessed March 15, 2022.
Treatment and new evidence in neuromyelitis optica spectrum disorders. Ideggyogy Sz. 2021; 74(9-10):309-321.
Liu Y, et al. Cerebral white matter diffusion in neuromyelitis optica shows generalized pathological abnormalities. Mult Scler. 2011; 18(7):1013-1021.
Chihara N, et al. Interleukin 6 signaling promotes anti-aquaporin-4 autoantibody production from plasmablasts in neuromyelitis optica. PNAS. 2011;108(9):3701-3706.
Duan T, Smith AJ, Verkamn AS. Complement-independent pass-through lesion in AQP4-IgG seropositive neuromyelitis optica produced by antibody-dependent cellular cytotoxicity. Acta Neuropathological Comm. 2019; 7(112).
Beekman J, et al. Neuromyelitis optica spectrum disorder: patient enjoyment and quality of life. Neuroinflammatory Neuroimmunol Neuroinflamm. 2019; 6(4):E580.
Kimbrough DJ and others. Treatment of neuromyelitis optica: and recommendations. Mult Scler Relationship Disorder. 2012; 1(4):180-187.
Baranello RJ, Avasarala, JR. Neuromyelitis optica spectrum disorders with antibodies to aquaporine four: characterization, differential diagnosis, and recent advances. J Neuro Ther. 2015; 1(1):9-14.
WingerchukDM. Neuromyelitis optica: of sex. J Neurol Sciences. 2009; 286(1-2):18-23.
Flanagan EP, et al. Epidemiology of aquaporin-4 autoimmunity and neuromyelitis optica spectrum. Ann Neurol. 2016;79(5):775-783.
SOURCE Horizon Therapeutics
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