UPLIZNA^® Now Available for Adults with anti-AChR+ and anti-MuSK+ gMG

MISSISSAUGA, ON, Oct. 13, 2026 /CNW/ -- Amgen Canada announced UPLIZNA^® (inebilizumab) is now available for prescription as an add-on treatment to standard therapy for adults living with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. For physicians and eligible patients in Canada, UPLIZNA introduces a new, targeted therapy option for people living with gMG, with the potential for long-term disease control through twice-yearly maintenance dosing following two initial loading doses.¹

Generalized myasthenia gravis is a rare, chronic B-cell-mediated autoimmune disease that causes fluctuating muscle weakness and can make everyday activities such as speaking, swallowing and moving around unpredictable from day to day. It is a subtype of myasthenia gravis (MG), which is estimated to affect 30 in every 100,000 people in Canada.^2,3,4

"Many patients with gMG depend on steroids to help control the disease and are unable to reduce the dose below current MG recommended treatment goals. We know that a cumulative dose of steroids over time can come with significant side effects,⁵" said Dr. Carolina Barnett-Tapia, Associate Professor of Medicine (Neurology) at the University of Toronto. "UPLIZNA offers a new treatment option that may help reduce reliance on steroids, with the potential for long-term disease control and twice-yearly maintenance dosing that can make ongoing treatment easier for patients."

Health Canada's authorization of UPLIZNA is supported by data from the Inebilizumab in Generalized Myasthenia Gravis Trial (MINT), the largest Phase 3 biologic study to include both AChR+ and MuSK+ patients, and the first to successfully incorporate a structured steroid-tapering protocol. Patients receiving steroids at baseline began tapering at Week 4 with a goal of reaching prednisone 5 mg. By Week 26, 87.4 per cent of patients taking UPLIZNA and 84.6 per cent of those taking placebo had reduced their steroid dose to 5 mg or less per day.⁶

"This approval marks an important advancement for people in Canada living with gMG, a condition marked by unpredictable, debilitating symptoms," said Daniel Martinez, Executive Medical Director, Amgen Canada. "UPLIZNA's distinct CD19-targeting mechanism depletes B-cells, acting on an underlying driver of disease and helping meet significant unmet clinical needs in patients with anti-AChR- or anti-MuSK antibody-positive gMG.¹"

The launch of UPLIZNA for gMG in Canada builds on its established use in treating other rare autoimmune diseases. In Canada, UPLIZNA is also approved as a monotherapy for adult patients with neuromyelitis optica spectrum disorder (NMOSD), who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive, and became the first treatment approved for adult patients with Immunoglobulin G4-related disease (IgG4-RD) in 2025.¹

To support Canadians living with gMG, Amgen provides access to the Amgen Entrust Rare Patient Support Program, offering personalized assistance throughout the treatment journey. Healthcare professionals can enroll eligible patients into the program to access resources and support services designed to facilitate treatment access and continuity of care. Enrollment and program assistance are available by phone at 1-844-601-RARE (1-844-601-7273), by email at uplizna@entrustrare.ca, or by fax at 1-888-343-0933, Monday through Friday from 8 a.m. to 8 p.m. ET.

About Generalized Myasthenia Gravis (gMG)
Generalized myasthenia gravis (gMG) is a rare, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause muscle weakness, trouble breathing, difficulty swallowing and impaired speech and vision.^2,3,4

Approximately 85 per cent of patients with myasthenia gravis have the generalized form, or gMG.^7,8 The prevalence and incidence of gMG are increasing worldwide.⁹ Approximately 85 per cent of patients with myasthenia gravis have detectable antibodies against AChR, and approximately seven per cent have detectable antibodies against MuSK.⁷ Global prevalence is estimated at two to 36 cases per 100,000.¹⁰ The disease is more frequently seen in young women (age 20 to 39) and men aged 50 years and older.¹¹

B-cells are central to the pathogenesis of gMG. The disease is thought to be primarily driven by pathogenic CD19+ plasmablasts and plasma cells that target critical proteins in the neuromuscular junction.^2,3,11

About UPLIZNA^® (inebilizumab)
UPLIZNA is a humanized monoclonal antibody (mAb) that causes targeted and sustained depletion of key cells that contribute to the underlying disease process (autoantibody-producing CD19+ B-cells, including plasmablasts and some plasma cells). The precise mechanism by which UPLIZNA exerts its therapeutic effects is unknown. After two initial infusions, patients need one maintenance dose of UPLIZNA every six months.¹

For additional information about UPLIZNA, including important safety information, dosing and administration, please consult the Canadian Product Monograph.

About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ontario's vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new uses for existing medicines in partnership with many of Canada's leading healthcare, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca. 

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MEDIA CONTACT:
Quentin Bourgaud
Amgen
qbourgau@amgen.com

SOURCE Amgen Canada