BENLYSTA now approved in Canada in addition to standard therapy for treatment of active lupus nephritis in adult patients

Mississauga, ON – BENLYSTA (belimumab) has been approved in Canada for the treatment of active lupus nephritis (LN) in adult patients.[i] BENLYSTA is available as an intravenous infusion  and a subcutaneous injection.

BENLYSTA has been available in Canada as an intravenous infusion since 2011 to reduce disease activity in adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE). It was the first SLE-specific treatment approved in over 50 years. Since then, BENLYSTA has also been approved for subcutaneous injection. The recent approval extends the indication in Canada to include both LN and SLE.

BENLYSTA, a human monoclonal antibody, is the first and only biologic approved in Canada for systemic lupus erythematosus and lupus nephritis. This approval follows recent approvals in the US and EU for a similar expanded LN indication.

“Approximately 40% of patients with systemic lupus erythematosus develop active lupus nephritis, which causes inflammation in the kidneys and can lead to end-stage kidney disease. BENLYSTA is the first medicine approved to reduce SLE activity and treat adults with active lupus nephritis. This approval symbolizes new hope to many of the thousands of Canadians living with lupus, a complex and incurable autoimmune disease,” said Marni Freeman, Interim Country Medical Director at GSK Canada. “We’re proud to bring forward this important treatment advance, not only for Canadian lupus patients seeking options but also for the healthcare professionals who treat them.”

“This represents a critical step forward for lupus patients in Canada, many Canadian patients with systemic lupus erythematosus and active lupus nephritis should enjoy healthier and more active lifestyles with this new treatment alternative,” said Leanne Mielczarek, Executive Director, Lupus Canada. 

About systemic lupus erythematosus (SLE) and active lupus nephritis (LN)

Lupus is a disease of the body’s immune system, and it’s estimated that there are up to 50,000 Lupus patients in Canada. [ii] Health impacts can include skin rashes, ulcers and lesions, sensitivity to light, arthritis and joint pain, inflammation in the lining of the heart and lungs, seizures and other nerve problems.

Systemic lupus erythematosus (SLE), the most common form of lupus, is a chronic, incurable, autoimmune disease associated with a range of symptoms that can fluctuate over time including painful or swollen joints, extreme fatigue, unexplained fever, skin rashes and organ damage. In lupus nephritis (LN), SLE causes kidney inflammation (swelling or scarring) of the small blood vessels that filter wastes in your kidney (glomeruli) and sometimes the kidneys, by attacking them like they would attack a disease.[iii] LN can lead to end-stage kidney disease, which requires kidney dialysis or a transplant. Despite improvements in both diagnosis and treatment over the last few decades, LN remains an indicator of poor prognosis.[iv][v] Manifestations of LN include proteinuria, elevations in serum creatinine and the presence of urinary sediment.


BENLYSTA, a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. BENLYSTA does not bind B cells directly. By binding BLyS, BENLYSTA inhibits the survival of B cells, including autoreactive B cells, and reduces the differentiation of B cells into immunoglobulin-producing plasma cells.

Please consult the Product Monograph at for complete safety information. The Product Monograph is also available by calling 1-800-387-7374.

About GSK 

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[i] BENLYSTA Canadian Product Monograph, July 2021

[ii]Lupus Canada. Available from: Accessed July 2021.

[iii] National Kidney Foundation, Lupus and Kidney Disease (Lupus Nephritis).  Available at

[iv] Gordon C, Hayne D, Pusey C, et al. European Consensus Statement on the Terminology used in the Management of Lupus Glomerulonephritis. Lupus 2009;18:257-26.

[v] Waldman M and Appel GB. Update of the Treatment of Lupus Nephritis. Kidney International 2006;70:1403-1412.