European Commission Approves Roche's PiaSky For Paroxysmal Nocturnal Hemoglobinuria

(RTTNews) - Roche (RHHBY) announced that the European Commission has approved PiaSky (crovalimab), a novel recycling monoclonal antibody that inhibits the complement protein C5. It is approved for adults and adolescents (12 years of age or older, with a weight of 40 kg or more) with paroxysmal nocturnal hemoglobinuria, whether they are new to treatment or have previously been treated with C5 inhibitors.

The approval is based on the results from the Phase III COMMODORE 2 study in people with paroxysmal nocturnal hemoglobinuria who have not been previously treated with C5 inhibitors. The study demonstrated that PiaSky, administered as subcutaneous (SC) injections every four weeks, achieved disease control and was well-tolerated. PiaSky was non-inferior with comparable safety to eculizumab, an existing standard of care C5 inhibitor, given intravenously every two weeks.

The company noted that PiaSky is the first monthly subcutaneous (SC) treatment for PNH in the European Union, with the option to self-administer following adequate training. It provides an alternative option to current C5 inhibitors that require regular intravenous infusions.

Paroxysmal nocturnal hemoglobinuria or 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 anaemia, fatigue and blood clots, and potentially leading to kidney disease.

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