European Commission approves Roche’s PiaSky for paroxysmal nocturnal hemoglobinuria

SOUTH SAN FRANCISCO (dpa-AFX) – 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, weighing 40 kg or more) with paroxysmal nocturnal hemoglobinuria, regardless of whether they are new to treatment or have previously been treated with C5 inhibitors.

The approval is based on results from the Phase III COMMODORE 2 trial in people with paroxysmal nocturnal hemoglobinuria who were previously untreated with C5 inhibitors. The trial 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 C5 inhibitor administered 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 after adequate training. It offers an alternative option to current C5 inhibitors that require regular intravenous infusions.

Paroxysmal nocturnal hemoglobinuria or PNH is a rare and life-threatening blood disorder in which red blood cells are destroyed by the complement system (part of the innate immune system). This causes symptoms such as anemia, fatigue and blood clots and can potentially lead to kidney disease.

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