Canada’s Drug Agency Issues Positive Reimbursement Recommendation for EMPAVELI® (pegcetacoplan) for the Treatment of C3G and Primary IC-MPGN

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This recommendation represents an important step towards improving access for Canadians living with rare kidney diseases

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WALTHAM, Mass., July 09, 2026 (GLOBE NEWSWIRE) — Swedish Orphan Biovitrum AB (publ) (Sobi™) (STO:SOBI) is pleased to announce that Canada’s Drug Agency (CDA) has issued a positive reimbursement recommendation with conditions for PrEMPAVELI^® (pegcetacoplan) for the treatment of adult and adolescent patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) to reduce proteinuria.

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EMPAVELI^® is the first treatment authorized in Canada for C3G or primary IC-MPGN. The positive recommendation from CDA marks an important milestone in the reimbursement process for public drug plans across Canada.

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“CDA’s positive reimbursement recommendation for EMPAVELI^® is encouraging news for Canadians living with C3G and primary IC-MPGN, two rare and serious kidney diseases with significant unmet need,” said Bob McLay, Vice President and General Manager, Sobi Canada. “This recommendation reflects the importance of improving access to innovative therapies for patients and families who have historically faced limited treatment options and a high risk of disease progression and kidney failure.”

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The CDA recommendation was informed by data from the Phase 3 VALIANT study, the largest single clinical trial conducted in patients with C3G and primary IC-MPGN. The study evaluated pegcetacoplan in 124 patients aged 12 years and older and demonstrated clinically meaningful reductions in proteinuria, stabilization of kidney function, and clearance of C3 deposits.

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“Patients living with C3G and primary IC-MPGN face significant uncertainty due to the progressive nature of these diseases and the lack of disease modifying treatment options historically available” said Dr. Christoph Licht, Head, Division of Nephrology, SickKids, The Hospital for Sick Children, Toronto. “A positive reimbursement recommendation for EMPAVELI^® is an important step toward helping eligible patients access a therapy specifically designed to target the underlying complement-mediated disease process.”

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C3G and primary IC-MPGN are rare kidney diseases driven by uncontrolled activation of the complement system, leading to inflammation and kidney damage. Approximately 50 percent of people living with these diseases experience kidney failure within five to 10 years of diagnosis, often requiring dialysis or kidney transplantation. Disease recurrence following transplant is also common. ^1-3

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EMPAVELI® (pegcetacoplan) is a targeted C3 and C3b therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases.