Posted by Michael Wonder on 01 Jul 2024
CHMP recommends EU approval of Roche’s PiaSky for people with PNH, a rare, life-threatening blood condition
28 June 2024 - The recommendation is based on the COMMODORE 2 study results, where SC PiaSky given every month demonstrated equivalent disease control and comparable safety to IV eculizumab given every two weeks.
Roche announced today that the EMA's CHMP has adopted a positive opinion for PiaSky (crovalimab) for the treatment of paroxysmal nocturnal haemoglobinuria.
