Posted by Michael Wonder on 12 Jun 2025
Health Canada authorises PiaSky (crovalimab for injection) as the first monthly (every four weeks) subcutaneous treatment for people with paroxysmal nocturnal haemoglobinuria
11 June 2025 - Roche Canada is pleased to announce that Health Canada has authorised PiaSky (crovalimab for injection) as the first monthly (every four weeks) subcutaneous therapy indicated for the treatment of paroxysmal nocturnal haemoglobinuria in adults and adolescents 13 years of age and older with a body weight of at least 40 kg.
Health Canada's authorisation of PiaSky is based on the pivotal COMMODORE 2 Phase III study in people with paroxysmal nocturnal haemoglobinuria who have not previously been treated with C5 inhibitors.
