Swedish Orphan Biovitrum AB (publ) (SWOBYI,BIOVF,SOBI.ST), a biopharmaceutical company, announced that Health Canada has approved EMPAVELI or Pegcetacoplan 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).
C3G and primary IC-MPGN are rare and debilitating kidney diseases that can lead to kidney failure, and people living with C3G or primary IC-MPGN suffer from kidney failure within five to 10 years of diagnosis, requiring an arduous kidney transplant or dialysis therapy.
This approval is based on positive results from the Phase 3 VALIANT study, conducted in 124 patients aged 12 years and older with C3G or primary IC-MPGN.
EMPAVELI demonstrated benefits across the three key endpoints identified by the Kidney Health Initiative (KHI) C3G Trial Endpoints Working Group, including a significant reduction in proteinuria, a 68% relative reduction in Urine Protein-to-Creatinine Ratio (uPCR), stabilisation of kidney function, and substantial clearance of C3(Complement component 3 protein) deposits.
"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.
The firm estimated that approximately 700 people in Canada, 5,000 in the United States, and up to 8,000 in Europe are affected by C3G and primary IC-MPGN disease. SOBI's key therapy areas include Haematology, Immunology and rare metabolic conditions.
SOBI.ST has traded between 241.80 Swedish Kronor and 432.80 Swedish Kronor.
The stock is currently up 0.60% at $404.40 in the Stockholm market.
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