Enhanced Access to gMG Treatments: UCB Canada Secures pCPA Agreements for ZILBRYSQ® and RYSTIGGO®

• Important milestone brings eligible Canadians living with gMG one step closer to accessing innovative therapies ZILBRYSQ^® and RYSTIGGO^® through public reimbursement, marking progress towards increased patient access to two different mechanisms of action.

OAKVILLE, ON, Sept. 9, 2025 /CNW/ - UCB Canada Inc. is proud to announce that the pan-Canadian Pharmaceutical Alliance (pCPA) has successfully concluded negotiations for ^PrZILBRYSQ^® (zilucoplan injection) and ^PrRYSTIGGO^® (rozanolixizumab injection), marking an important milestone in creating access for these innovative therapies for Canadians living with generalized myasthenia gravis (gMG). UCB is the only company in Canada offering a portfolio with two different mechanisms of action for treating gMG. This significant milestone comes after successfully securing a positive reimbursement recommendation by CDA-AMC and recognition of therapeutic value by INESSS and is a necessary step for securing provincial public reimbursement as the next and final step.

ZILBRYSQ^® is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. ZILBRYSQ^® is the first and only self-administered subcutaneous injection approved in Canada for patients with AChR antibody positive gMG, fulfilling a substantial unmet need in this patient population.

RYSTIGGO^® 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. RYSTIGGO^® is a cyclical, subcutaneous infusion, dosed once weekly, for six consecutive weeks, and administered by a healthcare professional. It is the first and only Health Canada-approved treatment option for MuSK patients.

RYSTIGGO^® and ZILBRYSQ^® address key unmet needs for Canadians living with gMG. Subcutaneous therapies provide meaningful clinical benefit while offering greater flexibility and independence than traditional intravenous treatments.ⁱ

ZILBRYSQ^®'s once-daily self-administration at home reduces clinic visits and supports patient independence, while RYSTIGGO^® offers a structured weekly treatment regimen administered by a healthcare professional^i,ii. RYSTIGGO^® has demonstrated improvements in muscle strength, reduction in fatigue, and enhancement of activities of daily living, while ZILBRYSQ^® provides rapid and clinically meaningful improvements in MG-specific outcomes, including muscle strength, composite disease measures, and quality-of-life scores^ii,iii,1.

"pCPA agreements mark a major step towards securing public reimbursement for both RYSTIGGO^® and ZILBRYSQ^®, for Canadians living with generalized myasthenia gravis. With two distinct mechanisms of action now available, patients and clinicians have greater choice to pursue more personalized treatment approaches. This milestone represents renewed hope for the gMG community, expanding access and flexibility while setting a new standard of care in Canada," celebrates Lisa Arbuckle, UCB Canada Inc. Head of Rare & Epilepsy.

Health Canada approval for RYSTIGGO^® was supported by the Phase III MycarinG study, which demonstrated statistically significant improvements in MG-specific outcomes, including the MG-ADL, assessing activities such as breathing, talking, swallowing, and rising from a chairⁱⁱⁱ.

Health Canada approval for ZILBRYSQ^® was supported by the Phase III RAISE study, showing rapid, consistent, and clinically meaningful improvements in Myasthenia Gravis-Activities of Daily Living (MG-ADL), Quantitative Myasthenia Gravis (QMG) score, Myasthenia Gravis Composite (MGC) score and Myasthenia Gravis Quality of Life 15-item scale (MG-QoL15r)² – at week 12 in a broad population of mild to severe adult patients with AChR antibody positive gMGⁱⁱ.

"Public reimbursement of rozanolixizumab (RYSTIGGO^®) and zilucoplan (ZILBRYSQ^®) is a welcome step for eligible adults with generalized myasthenia gravis. As subcutaneous therapies with proven ability to reduce disease burden, these treatments expand options for this chronic neuromuscular disease and support individualized care tailored to patient needs. Having more than one therapy available is a meaningful advancement, giving patients greater choice, access, and hope for improved quality of life," said Hans Katzberg, MD, MSc, FRCPC, FAAN, Professor of Medicine, University of Toronto.

"For people living with generalized myasthenia gravis, timely access to innovative therapies is critical. The availability of ZILBRYSQ^® and RYSTIGGO^® through public reimbursement represents meaningful progress in addressing long-standing gaps for this community. To truly realize this impact, it is essential that all public jurisdictions act quickly with listings, ensuring that patients across Canada can benefit equally. These treatments not only offer new options, but also provide greater flexibility and independence for patients and families navigating the daily challenges of gMG," affirms Homira Osman, PhD, VP, Research and Public Policy, Muscular Dystrophy Canada.

As next step UCB is looking forward to working with the provincial drug formularies to secure listings for eligible patients living with gMG in Canada.

About Generalized Myasthenia Gravis:
Generalized myasthenia gravis (gMG) is a rare, chronic, autoimmune, neuromuscular disease where the body's immune system mistakenly targets the connection between the nerves and the muscles, causing weakness in the eyes, face, neck, arms, legs, and throat. Symptoms can appear suddenly, fluctuate in severity, and in some cases lead to a life-threatening myasthenic crisis^iv.

In Canada, it is estimated that 32 of every 100,000 people are affected^v, and women under 40 and men over 60 more likely to be diagnosed^vi. There is currently no cure, and many patients continue to face significant physical, emotional and economic challenges.^vii

About RYSTIGGO®:
RYSTIGGO^® 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. For more important information, consult the RYSTIGGO Product Monograph at https://www.ucb-canada.ca/en/rystiggo regarding warnings, precautions, adverse reactions, drug interactions, dosing, and conditions of clinical use. The Product Monograph is also available by calling UCB Canada at 1-866-709-8444.

About ZILBRYSQ^®:
ZILBRYSQ^® is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. Patients continued to receive standard therapy throughout the pivotal trial. For more important information, consult the ZILBRYSQ Product Monograph at www.ucbcanada.com/en/zilbrysq regarding contraindications, warnings, precautions, adverse reactions, drug interactions, dosing, and conditions of clinical use. The Product Monograph is also available by calling UCB Canada at 1-866-709-8444.

About UCB Canada Inc.:
UCB Canada Inc. is a biopharmaceutical company dedicated to discovering and developing innovative medicines and solutions to transform the lives of people living with severe autoimmune and central nervous system diseases. For more information, please visit https://www.ucb-canada.ca/. 

About UCB:
UCB is a global biopharmaceutical company focused on discovering and developing innovative medicines and solutions for severe diseases of the immune system or central nervous system. With more than 9,000 employees across nearly 40 countries, UCB is committed to making a meaningful difference in patients' lives worldwide. For more information, visit www.ucb.com. 

References 

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¹ "Clinically significant change" does not apply to this measure

² "Clinically significant change" does not apply to this measure

ⁱ Health Quality Ontario. Home-based immunoglobulin (SCIG) versus hospital-based intravenous immunoglobulin (IVIG) therapy: Health Technology Assessment. November 2017. https://www.hqontario.ca/Portals/0/documents/evidence/reports/hta-ig-home-infusion-1711.pdf. Accessed August 2025.

ⁱⁱ UCB Canada. ZILBRYSQ® (zilucoplan injection) Product Monograph. July 11, 2024. https://www.ucbcanada.com/sites/default/files/2025-02/ZILBRYSQ_English_Product%20Monograph_11Jul2024_0.pdf. Accessed August 2025.

ⁱⁱⁱ UCB Canada. RYSTIGGO® (rozanolixizumab injection) Product Monograph. March 28, 2025. https://www.ucbcanada.com/sites/default/files/2025-04/rystiggo_product_monograph_en_final_28mar2025.pdf. Accessed August 2025.

^iv UCB Canada. Myasthenia Gravis. https://www.ucb.com/solutions/diseases/myasthenia-gravis. Accessed August 2025.

^v 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. 

^vi National Institute of Neurological Disorders and Stroke. Myasthenia gravis. NINDS. Last Accessed: August 22, 2025. https://www.ninds.nih.gov/health-information/disorders/myasthenia-gravis 

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

SOURCE UCB Canada Inc.

For further information, please contact UCB: [email protected]