Roche’s PiaSky approved in the EU

The European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5, from Swiss pharma giant Roche (ROG: SIX).

PiaSky is authorized for adults and adolescents (12 years of age or older with a weight of 40 kg and above) with paroxysmal nocturnal hemoglobinuria (PNH) who are either new to, or have been previously treated with C5 inhibitors.

Roche noted that PNH is a rare and life-threatening blood condition where red blood cells are destroyed by the complement system – part of the innate immune system – causing symptoms such as anemia, fatigue and blood clots, and potentially leading to kidney disease.