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news.Roche Canada has received Health Canada’s authorisation for PiaSky (crovalimab for injection), to treat paroxysmal nocturnal haemoglobinuria (PNH).
PiaSky's approval was based on results from the COMMODORE 2 Phase III trial. Credit: National Cancer Institute/Unsplash.
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PiaSky will be given as the first monthly subcutaneous therapy for adults and adolescents aged 13 years or more with a minimum body weight of 40kg.
Patients have a choice to self-inject PiaSky after receiving primary intravenous (IV) infusion and subsequent weekly subcutaneous (SC) starter doses during the first month of therapy.
PNH is a rare and potentially fatal bone marrow disease characterised by the destruction of red blood cells.
Roche Pharma Canada president and CEO Brigitte Nolet said: “We are pleased to offer PiaSky as a new option to the treatment landscape for Canadians living with PNH.
“With a self-administration option available for appropriate patients, as determined by their doctor, individuals can choose to treat their disease at home without requiring IV access and feel empowered to take an active role in their own care.
“This flexibility of administration may help reduce treatment burden for patients, their caregivers, and healthcare systems, and is part of Roche’s ongoing commitment to bringing Canadians new therapies that have a broader value to society.”
PiaSky’s approval from Health Canada was based on results from the COMMODORE 2 Phase III trial involving patients with PNH who had not previously received C5 inhibitors.
The study found that monthly injections of PiaSky controlled the disease and were well-tolerated among participants.
Roche Canada aims to make this new treatment accessible through both public and private healthcare plans across the region in order to support patients.
