India, July 10 -- 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 popula...