Saphnelo® subcutaneous approved in Canada for the treatment of systemic lupus erythematosus

New self-administration option offers same clinical benefits as Saphnelo IV infusion

MISSISSAUGA, ON, April 13, 2026 /CNW/ - Health Canada has granted a Notice of Compliance (NOC) for Saphnelo^® (anifrolumab injection) for subcutaneous self-administration via a single-use autoinjector for adult patients with active, autoantibody positive systemic lupus erythematosus (SLE) in addition to standard therapy. The approval by Health Canada was based on positive results from the interim analysis of the Phase III TULIP-SC trial. In the trial, the subcutaneous administration of anifrolumab led to a statistically significant and clinically meaningful reduction in disease activity compared to placebo in participants with active, autoantibody positive SLE while receiving standard therapy.^1,2    

"We have witnessed the benefit that Saphnelo IV infusion has had on significantly reducing disease activity and limiting long-term organ damage for those living with SLE," said Dr. Zahi Touma, Dr. Murray B. Urowitz Chair in Lupus Research at UHN and Director, Toronto Lupus Program at UHN. "The approval of the new subcutaneous formulation represents a significant advancement in providing a new delivery option for Canadians living with this complex disease."

Lupus is a debilitating autoimmune condition that affects approximately 1 in 1,000 Canadians.³ It primarily affects women, often onset from young adulthood and can cause pain, rashes, fatigue, swelling in joints and fevers.^4-8 People with SLE have a two to three times increased risk of death compared to the overall population.⁹ While oral corticosteroids are often used for relief from symptoms of SLE, they are associated with adverse events and short-term benefits without targeting the underlying drivers of the disease, preventing patients from experiencing adequate disease control and achieving remission.^10-12

"Lupus is often invisible, yet its impact is constant, as those living with the disease can experience painful, debilitating symptoms every day," said Leanne Mielczarek, CEO of Lupus Canada. "Today's announcement provides a much-needed innovation for people living with lupus to manage their disease."

About TULIP-SC 
TULIP-SC was a Phase III, multicentre, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of a subcutaneous administration of anifrolumab versus placebo in participants aged 18 to 70 years with moderately to severely active, autoantibody-positive SLE while receiving standard therapy (oral corticosteroids, antimalarial, and/or immunosuppressants).¹⁸

Saphnelo met the primary endpoint of reduction of disease activity and measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52.^2,18 The BICLA requires improvement in all organs with disease activity at baseline with no new flares.¹⁸  The medicine also met key secondary endpoints including reduction of disease activity, measured using BICLA, while maintaining low/reduced oral glucocorticoid doses.

The overall safety profile of Saphnelo observed in the interim analysis of the TULIP-SC trial was generally consistent with the known clinical profile of the medicine administered as an intravenous (IV) infusion. The adverse reactions reported during anifrolumab treatment in the 3 intravenous and 1 subcutaneous clinical trials were upper respiratory tract infection (30.9%), bronchitis (10.2%), infusion-related reaction (9.4%), herpes zoster (6.0%), respiratory tract infection (3.0%), hypersensitivity (2.5%), and anaphylactic reaction (unknown).

The primary endpoint was reported at the interim analysis; however, this was preplanned, with no changes to the eligibility criteria of patients or study procedures between the interim and full analysis, and the consistency of the results from the interim and full analyses supports the findings of the study. Patients with active severe or unstable neuropsychiatric SLE or active severe lupus nephritis were excluded, and so conclusions about the efficacy of SC anifrolumab in these patients cannot be drawn.¹⁸

About Anifrolumab
Anifrolumab is a first-in-class, fully human monoclonal antibody that binds to subunit 1 of the type I interferon (IFN) receptor, blocking the activity of type I IFN.^19,20 Type I IFNs, such as IFN-alpha, IFN-beta and IFN-kappa, are cytokines involved in regulating the inflammatory pathways implicated in SLE.^21-26

The treatment continues to be evaluated in diseases where type I IFN plays a key role, including Phase III trials in cutaneous lupus erythematosus, myositis, systemic sclerosis and lupus nephritis.^27-30  

Saphnelo IV infusion was first approved by Health Canada in 2021 in addition to standard therapy for the treatment of adult patients with active, autoantibody positive, systemic lupus erythematosus (SLE).

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and Biopharmaceuticals, including Cardiovascular, Renal & Metabolic, and Respiratory & Immunology. In Canada, the company employs roughly 2,675 people and was recently named one of Canada's Top 100 Employers for the third consecutive year. AstraZeneca is one of Canada's leading R&D contributors across all sectors. Together with Alexion Rare Disease and Fusion Pharmaceuticals, AstraZeneca is delivering more than 180 clinical studies across Canada – in such areas as breast, lung, and urothelial cancers, COPD, acute kidney failure, and hypophosphatasia (HPP). Visit www.astrazeneca.ca for more information.

The content in this document is for Canadian audiences only.

References
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SOURCE AstraZeneca Canada Inc.

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