EMPAVELI (pegcetacoplan) is the first approved treatment for C3G or primary IC-MPGN for patients 12 years and older in Canada
Approval supported by Phase 3 52-week VALIANT study demonstrated reduced proteinuria, stabilized kidney function and C3 deposit clearance
WALTHAM, Mass., April 09, 2026 (GLOBE NEWSWIRE) -- Swedish Orphan Biovitrum AB (publ) (Sobi) (STO:SOBI) announced today that Health Canada has approved EMPAVELI(pegcetacoplan), a complement inhibitor, for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) to reduce proteinuria.
EMPAVELI is a targeted C3 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.
"Health Canada's approval of EMPAVELI for the treatment of C3G or primary IC-MPGN marks an important milestone for patients and families in Canada living with these rare and serious kidney diseases," said Bob McLay, VP, General Manager of Sobi Canada. "For many in the kidney community, there have been limited treatment options and a long wait for new therapeutic advances. This approval brings renewed hope to patients and caregivers by providing a treatment option that stabilizes kidney function, addresses the underlying disease process and is supported by strong clinical evidence. We are proud to bring this important therapy to patients in Canada and remain committed to supporting the community as access expands."
C3G and primary IC-MPGN are rare kidney diseases affecting approximately 700 patients in Canada. More than half of people living with C3G or primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or dialysis therapy.1-3
This approval is based on positive results from the Phase 3 VALIANT study, in which EMPAVELI demonstrated benefits across the three key endpoints identified by the Kidney Health Initiative (KHI) C3G Trial Endpoints Working Group, including significant reduction in proteinuria (68% relative reduction in uPCR), stabilization of kidney function, and substantial clearance of C3 deposits. These positive results were recently published in The New England Journal of Medicine.6
Sobi and its partner Apellis Pharmaceuticals, Inc. have global co-development rights for systemic pegcetacoplan.
About C3 Glomerulopathy (C3G) and Primary Immune-Complex Membranoproliferative Glomerulonephritis (IC-MPGN)
C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure. Excessive C3 deposits are a key marker of disease activity, which can lead to kidney inflammation, damage, and failure. Approximately 50% of people living with C3G or primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring a burdensome kidney transplant or dialysis therapy.1-3 Additionally, approximately 90% of patients who previously received a kidney transplant will experience disease recurrence.4 The diseases are estimated to affect 5,000 people in the United States and up to 8,000 in Europe.5
About the VALIANT Study
The VALIANT Phase 3 study (NCT05067127) was a randomized, placebo-controlled, double-blinded, multi-center study that evaluated pegcetacoplan efficacy and safety in 124 patients who were 12 years of age and older with C3G or primary IC-MPGN. It is the largest single trial conducted in these populations and the only study to include pediatric and adult patients, with native and post-transplant kidneys. Study participants were randomized to receive pegcetacoplan or placebo twice weekly for 26 weeks. Following this 26-week randomized controlled period, patients were able to proceed to a 26-week open-label phase in which all patients received pegcetacoplan. The primary endpoint of the study was the log transformed ratio of urine protein-to-creatinine ratio (UPCR) at Week 26 compared to baseline.
About EMPAVELI (pegcetacoplan
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. It is the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older approved in the United States, European Union, Canada and other countries globally.
EMPAVELI is also approved for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH) in Canada, the United States, European Union, and other countries globally.
About the Sobi and Apellis Collaboration
Apellis and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive non-U.S. commercialization rights for systemic pegcetacoplan. Apellis has exclusive U.S. commercialization rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.
Sobi
Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 1,900 employees across Europe, North America, the Middle East, Asia and Australia. In 2025, revenue amounted to SEK 28 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.
Contacts
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References
1. Smith RJH, et al. Nat Rev Nephrol. 2019;15(3):129-143.
2. Servais A, et al. Kidney Int. 2012;82(4):454-464.
3. Zand L, et al. J Am Soc Nephrol. 2014;25(5):1110-1117.
4. Tarragón, B, et al. Clin J Am Soc Nephrol 2024; 19(8)1005-1015.
5. Data on file using literature consensus.
6. Fakhouri F, et al. N Engl J Med 2025;393:2210-2220
7. Nester C. et al., Clin J Am Soc Nephrol 2024 19(9):1201-1208.
