Posted by Michael Wonder on 10 Dec 2022
Sobi receives approval from Health Canada for Empaveli (pegcetacoplan) for the treatment of certain patients with paroxysmal nocturnal haemoglobinuria
9 December 2022 - Approval based on results from head to head PEGASUS Phase 3 trial where Empaveli demonstrated superiority to eculizumab in improving haemoglobin levels.
Sobi North America, the North American affiliate of Swedish Orphan Biovitrum (Sobi), announced today that Health Canada has approved Empaveli (pegcetacoplan), a complement inhibitor, for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria who have an inadequate response to, or are intolerant of, a C5 inhibitor.
