WALTHAM, Mass., July 09, 2026 – Canada’s Drug Agency (CDA) has issued a positive reimbursement recommendation, with conditions, for EMPAVELI® (pegcetacoplan) in the treatment of C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), Swedish Orphan Biovitrum AB (Sobi) announced. The recommendation covers patients aged 12 and older and applies specifically to reducing proteinuria in these two rare kidney conditions.
First Authorized Treatment For These Rare Kidney Diseases in Canada
EMPAVELI is currently the only therapy authorized in Canada for C3G or primary IC-MPGN. CDA’s positive recommendation moves the drug a step closer to public plan coverage nationwide, opening the reimbursement discussion that Canadian patients and clinicians have been waiting on since Health Canada’s approval earlier this year.
Bob McLay, Vice President and General Manager of Sobi Canada, called the recommendation encouraging for the Canadian C3G and primary IC-MPGN community, pointing to the significant unmet need in these two rare and serious kidney diseases.
He said the decision underscores how important expanded access to newer therapies is for patients who have historically had few treatment options and faced a substantial risk of disease progression toward kidney failure.
VALIANT Trial Data Informed The Recommendation
CDA based its recommendation on results from the Phase 3 VALIANT study, the largest clinical trial run in C3G and primary IC-MPGN patients to date. The study enrolled 124 participants aged 12 and older and found that pegcetacoplan produced clinically meaningful drops in proteinuria, stabilized kidney function, and cleared C3 deposits associated with the disease.
Dr. Christoph Licht, Head of the Division of Nephrology at SickKids, The Hospital for Sick Children in Toronto, noted that C3G and primary IC-MPGN patients live with considerable uncertainty given how these diseases tend to progress and the historical absence of treatments that modify the disease course.
He described the positive reimbursement recommendation as a meaningful step toward getting eligible patients onto a therapy built specifically to target the complement-driven disease process underlying both conditions.
Understanding C3G And Primary IC-MPGN
Both conditions stem from uncontrolled activation of the complement system, a part of the immune system, which drives kidney inflammation and damage over time.
Roughly half of patients diagnosed with C3G or primary IC-MPGN develop kidney failure within five to ten years, often requiring dialysis or a transplant, and the diseases frequently recur even after a transplant.
What Happens Next?
With CDA’s recommendation issued, reimbursement negotiations with Canada’s public drug plans move to the pan-Canadian Pharmaceutical Alliance (pCPA) for the next stage of the process.
About The VALIANT Study
VALIANT (NCT05067127) was a randomized, double-blind, placebo-controlled trial conducted across multiple centers, evaluating pegcetacoplan in 124 patients aged 12 and older with C3G or primary IC-MPGN.
It is the largest single trial in this patient population and the only one to include both pediatric and adult participants with native or post-transplant kidneys.
Participants received either pegcetacoplan or placebo twice weekly for the first 26 weeks, after which all patients could continue into a 26-week open-label extension on pegcetacoplan.
The primary endpoint measured the log-transformed change in urine protein-to-creatinine ratio (UPCR) from baseline to week 26.
About EMPAVELI® (pegcetacoplan)
EMPAVELI is a targeted therapy directed at C3 and C3b, designed to regulate excessive activity in the complement cascade, an immune system pathway implicated in a range of serious diseases.
It holds the distinction of being the first approved treatment for C3G or primary IC-MPGN in patients 12 and older across the United States, European Union, Canada, and other markets.
EMPAVELI is also approved to treat adults with paroxysmal nocturnal hemoglobinuria (PNH) in Canada, the United States, the European Union, and additional countries.
About The Sobi And Apellis Collaboration
Apellis Pharmaceuticals and Sobi share global co-development rights for systemic pegcetacoplan. Sobi holds exclusive commercialization rights outside the United States, while Apellis retains exclusive U.S. commercialization rights for the systemic formulation and worldwide commercial rights for the ophthalmic formulation, including its use in geographic atrophy.
About Sobi
Sobi is a global biopharmaceutical company focused on rare disease innovation, employing roughly 1,900 people across Europe, North America, the Middle East, Asia, and Australia. The company reported SEK 28 billion in revenue for 2025. Sobi’s shares trade on Nasdaq Stockholm under the ticker SOBI.