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EU Panel Backs Sobi's Aspaveli for Treatment of Two Rare Kidney Diseases

MT Newswires·12/12/2025 09:51:08
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09:51 AM EST, 12/12/2025 (MT Newswires) -- Swedish Orphan Biovitrum (SOBI.ST), or Sobi, said Friday a European Medicines Agency committee recommended the approval of Aspaveli for treating C3 glomerulopathy and primary immune-complex membranoproliferative glomerulonephritis. The positive opinion from the regulator's Committee for Medicinal Products for Human Use covers the use of the drug in patients aged 12 years and older who are suffering from either of the two rare kidney diseases. The recommendation is supported by results from the phase 3 Valiant study, where Aspaveli showed "significant" reduction in proteinuria, stabilization of kidney function and "substantial" clearance of C3 deposits. The Swedish biopharmaceutical company expects a marketing authorization decision from the European Commission in the first quarter of 2026.