The European Commission (EC) has approved Roche’s recycling monoclonal antibody, PiaSky (crovalimab), for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) in adult and adolescent patients.
The antibody hinders the complement protein C5 and is the first monthly subcutaneous therapy for PNH approved in the European Union.
It offers a new option for patients at least aged 12 and weighing a minimum of 40kg.
PiaSky’s approval is underpinned by the outcomes of the Phase III COMMODORE 2 study, which targeted patients who had not previously received C5 inhibitors.
The randomised, open-label trial assessed the efficacy and safety of PiaSky versus eculizumab in PNH patients.
The antibody offered disease control through subcutaneous injections every four weeks and confirmed its comparable safety to eculizumab.
PiaSky demonstrated non-inferiority to eculizumab, with a similar rate of adverse events reported in patients.
The data from two additional Phase III studies, COMMODORE 1 and COMMODORE 3, further supported the application.
PiaSky provides a less invasive, monthly treatment option that can be self-administered after training.
It has been approved in several territories, including the US and Japan, based on the evidence from the COMMODORE studies.
Roche continues to evaluate PiaSky in an extensive clinical development programme that encompasses five Phase III studies and three earlier phase trials across complement-mediated diseases such as PNH, atypical haemolytic uremic syndrome and sickle cell disease.
Roche global product development head and chief medical officer Levi Garraway stated: “The PiaSky approval brings a new option to the PNH treatment landscape, combining the disease control achievable through C5 inhibition with a cutting-edge recycling technology that enables monthly subcutaneous administration.
“We are pleased to bring this new treatment to people with PNH in Europe with the hope it may lessen the treatment burden faced by many living with this condition.”
In July 2024 Roche reported a net income of SFr6.6bn ($7.4bn) in the first half of 2024, marking a 4% decline at constant exchange rates compared to SFr7.5bn in the same period of 2023.
