2 gMG drugs win public reimbursement coverage across Canada

UCB’s Rystiggo (rozanolixizumab-noli) and Zilbrysq (zilucoplan) have gained public reimbursement coverage across multiple Canadian provinces for adults with generalized myasthenia gravis (gMG).

Product listing agreements are now in place in British Columbia, Québec, Alberta, Saskatchewan, Nova Scotia, and Newfoundland and Labrador for both therapies, and in Ontario for Rystiggo, said UCB Canada, the Canadian affiliate of developer UCB.

Both therapies are also covered through federal programs, including Veterans Affairs Canada and the Non-Insured Health Benefits Program, and by some major private insurance plans. UCB Canada said it will continue to work with Ontario toward public reimbursement of Zilbrysq and with the remaining provinces and private payers for both therapies.

The reimbursement agreements are “an important milestone for people living with generalized myasthenia gravis,” Rodrigo Reis, UCB Canada’s general manager, said in a company press release.  “We are encouraged to see increased support for patients to access these therapies and remain committed to working collaboratively with remaining jurisdictions across Canada to advance timely and equitable access to treatment options for this patient population.”

Homira Osman, PhD, vice president of research, public policy and programs at Muscular Dystrophy Canada, said access to more treatments “enables shared decision-making aligned with individual health goals and lived experience.” Osman called on other provinces to take similar action.

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Immune system can cause havoc in gMG

In gMG, the immune system mistakenly produces self-reactive antibodies that damage proteins involved in the connection between nerves and muscles. This can cause weakness in the eyes, face, neck, arms, legs, and throat. MG symptoms can appear suddenly, vary in severity, and in some cases lead to a life-threatening myasthenic crisis characterized by severe weakness of the breathing muscles.

In most cases, self-reactive antibodies target the acetylcholine receptor (AChR), a protein on muscle cells that responds to nerve signals. Less frequently, other proteins involved in nerve-muscle communication are the target, such as muscle-specific tyrosine kinase (MuSK).

An estimated 26 people per 100,000 are affected across Canada, with women under 40 and men over 60 more commonly diagnosed.

“Generalized myasthenia gravis can severely impact patients’ mobility, strength, and ability to perform basic daily activities,” said Lisa Arbuckle, head of rare & epilepsy at UCB Canada. “For patients living with rare diseases like gMG, meaningful advances in care are crucial.”

Both therapies are given by under-the-skin (subcutaneous) injection, with options for at-home administration. They have distinct mechanisms of action, meaning they work in different ways, which UCB Canada says gives clinicians and patients multiple treatment options.

Rystiggo is designed to block the neonatal Fc receptor protein, preventing the recycling of harmful self-targeting antibodies and reducing their levels. Zilbrysq suppresses the complement cascade, a part of the immune system that contributes to gMG-related tissue damage.

Carolina Barnett-Tapia, MD, PhD, an associate professor of neurology at the University of Toronto, said therapies that can be self-administered at home “can make a real difference, offering greater flexibility for eligible patients and giving clinicians more ways to tailor care to individual needs.”

Zilbrysq, approved in Canada in 2024, is indicated for adults with gMG who are AChR antibody-positive. The approval was based on data from the RAISE Phase 3 clinical trial (NCT04115293). Zilbrysq significantly lessened muscle weakness and eased the impact of symptoms on daily living, as measured by the Quantitative MG (QMG) and MG Activities of Daily Living (MG-ADL) scales.

Rystiggo was approved in Canada last year. The treatment is indicated for adults with gMG who test positive for anti-AChR or anti-MuSK antibodies. Its approval was supported by results from the Phase 3 MycarinG trial (NCT03971422), which showed that Rystiggo was superior to a placebo at reducing QMG and MG-ADL scores, indicating less severe disease.

“Public reimbursement of Rystiggo and Zilbrysq provides eligible patients and their clinicians with additional subcutaneous treatment options,” Arbuckle said. “These options expand approaches to gMG management and support patients in achieving improvements in daily function.”