Sobi’s Aspaveli receives European Commission approval for treatment of two rare kidney diseases
Esme Needham | January 28, 2026 | News story | | Aspaveli, European Commission, Nephrology, sobi
Sobi has announced that its Aspaveli (pegcetacoplan) has received approval from the European Commission (EC) for the treatment of two rare kidney diseases in adult and adolescent patients: C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
The treatments have been approved for administration in combination with a renin-angiotensin system (RAS) inhibitor, unless RAS inhibitor treatment is not tolerated by the patient or otherwise contraindicated. The EC’s approval follows a positive opinion expressed by the Committee for Medicinal Products for Human Use (CHMP) in 2025.
C3G and IC-MPGN are both rare kidney diseases with a high rate of kidney failure: around 50% of people with these diseases undergo kidney failure within five to 10 years following their diagnosis. A further 90% of C3G or IC-MPGN patients who receive a kidney transplant will see their disease recur. The two diseases affect approximately 5,000 people in the US and up to 8,000 in Europe.
The approval is based on the phase 3 VALIANT study. The study aimed to evaluate the safety and efficacy of Aspaveli in patients over the age of 12: Aspaveli showed significant benefits in stabilisation of kidney function and reduction in proteinuria. Results of the study were published in The New England Journal of Medicine.
Sobi is a global biopharmaceutical company specialising in rare diseases. It shares the global development rights for Aspaveli with Apellis.
Lydia Abad-Franch, head of R&D and medical affairs and chief medical officer at Sobi, said: “The EC approval for Aspaveli represents an important milestone for people living with C3G or primary IC-MPGN in Europe, two severe and rare kidney diseases with limited treatment options and a high risk of progression to kidney failure.”
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