Roche’s PiaSky Receives European Approval for Rare Blood Disorder Treatment

Approval in Europe:
Roche's drug PiaSky (crovalimab) has been approved by the European Commission for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening blood disorder.

Treatment Details:
PiaSky is administered every four weeks and can be self-administered following adequate training, offering patients more flexibility and reducing the need for frequent clinic visits.

Clinical Trials:
The approval was supported by positive results from the phase III COMMODORE 2 trial, which demonstrated PiaSky's effectiveness in controlling the disease and its comparable safety to eculizumab, an existing standard treatment.

Global Impact:
PiaSky is already approved in the US, Japan, and China, and this European approval further expands its availability to patients worldwide.

Patient Benefits:
The monthly subcutaneous administration of PiaSky could offer patients and caregivers more freedom in their day-to-day lives, according to Levi Garraway, Roche's chief medical officer.