Posted by Michael Wonder on 27 Aug 2024
Roche’s PiaSky approved in the EU as the first monthly subcutaneous treatment for people with paroxysmal nocturnal haemoglobinuria
27 August 2024 - Approval is based on COMMODORE 2, where subcutaneous PiaSky once a month was equivalent to intravenous eculizumab every two weeks.
Roche announced today that the European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, for adults and adolescents (12 years of age or older with a weight of 40 kg and above) with paroxysmal nocturnal haemoglobinuria who are either new to, or have been previously treated with C5 inhibitors.
