[Pr]RYSTIGGO® Now Approved for Adults with Generalized Myasthenia Gravis (gMG) in Canada

• RYSTIGGO^® (rozanolixizumab injection) is indicated for the treatment of adult patients with generalized Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.¹
• The approval is supported by the pivotal Phase III MycarinG study in gMG,² which demonstrated that treatment with RYSTIGGO results in statistically significant improvements in gMG-specific outcomes, including MG-ADL which assesses everyday activities such as breathing, talking, swallowing, and being able to rise from a chair.³
• Health Canada's approvals of RYSTIGGO and ZILBRYSQ for adults with gMG demonstrates UCB's commitment to advancing science in severe neurological and autoimmune diseases, addressing the gMG community's unmet needs and improving clinical outcomes.

OAKVILLE, ON, April 1, 2025 /CNW/ - UCB Canada Inc. is pleased to announce that ^PrRYSTIGGO^® (rozanolixizumab injection) has received authorization from Health Canada for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.¹ gMG is a rare, chronic autoimmune neuromuscular condition that causes skeletal muscle weakness, affecting the muscles of the eyes, face, neck, arms, legs, and throat. The onset of symptoms is usually quick and there is no cure.⁴

RYSTIGGO is a subcutaneous administered, humanized monoclonal antibody that specifically binds, with high affinity, to human neonatal Fc receptor (FcRn). It has been designed to block the interaction of FcRn and Immunoglobulin G (IgG), accelerating the catabolism of antibodies and reducing the concentration of pathogenic IgG autoantibodies.⁵

"Health Canada's approval of RYSTIGGO further supports UCB Canada's commitment to advancing care for the gMG community," said Rodrigo Reis, General Manager, UCB Canada. "With two therapeutic solutions now approved in Canada for gMG, our focus now will be to secure reimbursement so that patients can benefit from these treatments. At the same time, our ambition remains on continuing to develop innovative solutions that raise the standard of care and make a meaningful difference in the lives of people affected by gMG and other rare diseases."

Health Canada approval of RYSTIGGO is based on UCB's MycarinG study which demonstrated that treatment with rozanolixizumab resulted in improved MG related activities of daily living. Improvements in fatigue and muscle weakness were also observed.²

"gMG can cause unpredictable fluctuations in severity and frequency of symptoms, which are often debilitating and can substantially impact the lives of patients. People living with gMG often face treatment options that are broad-acting, and that have traditionally only offered symptomatic relief," explained Professor Vera Bril, Professor of Medicine (Neurology), University of Toronto, Director of the Neuromuscular Section, Division of Neurology, University of Toronto and University Health Network, Toronto, and lead investigator of the MycarinG study. "There is a significant need for new, innovative treatment options to reduce the day-to-day burden of gMG. Rozanolixizumab is a new treatment option, targeting one of the mechanisms of gMG to provide symptom improvement in patient-and physician reported outcomes at day 43."

"Generalized myasthenia gravis can profoundly impact a person's physical, emotional, social, and financial well-being. The unpredictable and fluctuating symptoms can be debilitating, significantly affecting patients' day-to-day lives," said Stacey Lintern, Chief Executive Officer, Muscular Dystrophy Canada. "The gMG community in Canada has long awaited new treatment options that extend beyond symptom-management and offer the potential to improve outcomes and reduce burden. The availability of a new treatment option that promises to enhance the quality of life for many Canadians brings new hope and  marks a significant step forward in the ongoing need for improved and accessible treatment options for gMG."

UCB is currently assessing the timeline of availability for RYSTIGGO and is committed to bringing this treatment to Canadians living with gMG as quickly as possible.

About Generalized Myasthenia Gravis
Generalized Myasthenia Gravis (gMG) is a rare chronic, autoimmune neuromuscular disease characterized by muscle weakness that worsens after periods of activity and improves after periods of rest. gMG can affect people of all races, ages and genders but is not thought to be directly inherited, nor is it contagious.^6,7

Approximately 32 out of every 100,000 people are living with gMG⁸ and it affects each person differently. Common symptoms include chronic fatigue and weakness in different muscle groups, that can impact daily activities – such as tooth-brushing, hair-combing, speaking (dysarthria) or swallowing (dysphagia) – and quality of life. In addition, symptom severity can increase unexpectedly, and might lead to hospitalization.⁵

gMG can have a significant economic impact on those living with it, with loss of income and lack of funds for emergency care cited as particularly challenging.⁹ The condition is associated with substantial healthcare costs and resource use, with hospitalization being the most significant factor.¹⁰

About the MycarinG Study
Heath Canada approval is supported by safety and efficacy data from the pivotal Phase 3 MycarinG study (NCT03971422), published in The Lancet Neurology in May 2023. The primary efficacy endpoint was the comparison of the change from baseline between treatment groups in the MG-ADL total score at day 43. MG-ADL is an 8 item measurement tool developed to assess MG symptoms and their effects on daily activities. These include activities such as breathing, talking, swallowing, and being able to rise from a chair. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function.³ A total score ranges from 0 to 24, with higher scores indicating more impairment. A statistically significant difference favoring rozanolixizumab was observed in the MG-ADL total score change from baseline [-3.4 points in rozanolixizumab- ≈7mg/kg treated group vs -0.8 in the placebo-treated group (p<0.001)].² 

The secondary endpoint was the change between treatment groups from baseline to day 43 in the QMG. The QMG is a 13-item categorical grading system that assesses muscle weakness. Each item is assessed on a 4-point scale where a score of 0 represents no weakness and a score of 3 represents severe weakness. A total possible score ranges from 0 to 39, where higher scores indicate more severe impairment. A statistically significant difference favoring rozanolixizumab was observed in the QMG total score change from baseline
[-5.4 points in rozanolixizumab ≈7mg/kg treated group vs -1.9 points in the placebo-treated group (p<0.001)].² 

About UCB Canada Inc.
Inspired by patients and driven by science, UCB Canada Inc. is a biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe autoimmune and central nervous system diseases. For more information, please consult https://www.ucb-canada.ca/.

About UCB
UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 8,400 people in nearly 40 countries, the company generated revenue of €5.3 billion in 2020. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCB_news. 

UCB and the UCB logo are registered trademarks of the UCB Group of Companies. ^PrRYSTIGGO^® is a registered trademark of UCB Biopharma SLR. © 2025 UCB Canada Inc. 2201-602 Bristol Circle, Oakville, ON, L6H 0J8. All rights reserved.

Date of Approval: March 2025 | CA-RZ-2500001

References

¹ RYSTIGGO Product Monograph. rystiggo_product_monograph_en_final_28mar2025.pdf. Accessed April 1, 2025.

² Bril V, Drużdż A, Grosskreutz J, Habib AA, Mantegazza R, Sacconi S, Utsugisawa K, Vissing J, Vu T, Boehnlein M, Bozorg A, Gayfieva M, Greve B, Woltering F, Kaminski HJ; MG0003 study team. Safety and efficacy of rozanolixizumab in patients with generalised myasthenia gravis (MycarinG): a randomised, double-blind, placebo-controlled, adaptive phase 3 study. Lancet Neurol. 2023 May;22(5):383-394. doi: 10.1016/S1474-4422(23)00077-7. Erratum in: Lancet Neurol. 2023 Oct;22(10):e11. doi: 10.1016/S1474-4422(23)00336-8. PMID: 37059507.

³ Wolfe G, et al. Myasthenia gravis activities of daily living profile. Neurology. 1992;52(7):1487-9

⁴ Cleveland Clinic. Myasthenia Gravis (MG), Myasthenia Gravis: What It Is, Causes, Symptoms & Treatment (clevelandclinic.org). Accessed May 2024.

⁵ Smith B, et al. Generation and characterization of a high affinity anti-human FcRn antibody, rozanolixizumab, and the effects of different molecular formats on the reduction of plasma IgG concentration. MAbs. 2018;10:1111-30.

⁶ National Institute of Neurological Disorders and Stroke. What is Myasthenia Gravis. www.ninds.nih.gov/health-information/disorders/myasthenia-gravis. Accessed May 2024.

⁷ Muscular Dystrophy Canada. Myasthenia Gravis: Know All About It. ALE19SO021024_PSPMGDiseasesBrochure_E7_v2.pdf (muscle.ca). Accessed May 2024.

⁸ Bubuioc, A. M., Kudebayeva, A., Turuspekova, S., Lisnic, V., & Leone, M. A. (2021). The epidemiology of myasthenia gravis. Journal of medicine and life, 14(1), 7–16. https://doi.org/10.25122/jml-2020-0145.

⁹ Hughes Tom et al. The economic burden of individuals living with generalized myasthenia gravis and facing social determinants of health challenges. Front Public Health. 2023 Sep 12:11:1247931. https://pubmed.ncbi.nlm.nih.gov/37766748/. Accessed June 2024.

¹⁰ Zhdanava, M et al. Economic burden of generalized myasthenia gravis (MG) in the United States and the impact of common comorbidities and acute MG-events. Current Medical Research and Opinion, 1–9. www.tandfonline.com/doi/full/10.1080/03007995.2024.2353381. Accessed June 2024.

SOURCE UCB Canada Inc.

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