加拿大药品机构有条件建议报销 Sobi 的 EMPAVELI 用于罕见肾病

Canada's Drug Agency Backs EMPAVELI For Rare Kidney Disease
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By
TajSabreen Ahamed
✉
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Published:
7/10/2026 12:27 AM ET
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Swedish Orphan Biovitrum AB (Sobi) (
SWOBY
) announced that Canada's Drug Agency (CDA) has issued a positive reimbursement recommendation with conditions for EMPAVELI (pegcetacoplan) in adults and adolescents aged 12 years and older with C3 glomerulonephritis, and primary immune-complex membranoproliferative glomerulonephritis.
According to the company's disclosures, EMPAVELI is the first treatment authorized in Canada for these rare kidney diseases, which are driven by uncontrolled complement activation and often lead to kidney failure within five to ten years of diagnosis.
Canada's Drug Agency's (CDA) recommendation was informed by results from the Phase 3 VALIANT study, the largest trial conducted in these patient populations, which demonstrated clinically meaningful reductions in proteinuria, stabilization of kidney function, and clearance of C3 deposits.
Sobi highlighted that the decision represents a milestone toward improving access for patients who have historically faced limited treatment options and a high risk of disease progression. Reimbursement discussions will now proceed through the pan-Canadian Pharmaceutical Alliance.
EMPAVELI, a targeted C3 therapy, is already approved in multiple regions for C3 glomerulopathy (C3G), immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and paroxysmal nocturnal hemoglobinuria (PNH). Sobi, which holds exclusive commercialization rights outside the U.S., underscored its commitment to expanding access to innovative therapies for rare diseases globally.
SWOBY has traded between $13.57 and $29.32 over the past year. The stock closed Thursday's trading at $25.00.
For comments and feedback contact: editorial@rttnews.com
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