Roche (RHHBY.US) announced that the human drug committee (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on its new generation C5 circular antibody Piasky (crovalimab, cofar single antibody) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH). CHMP recommends that PiaSky be used in adults and adolescents (12 years of age and older and weighing not less than 40 kg) who have not received or have already received C5 inhibitors. If approved, PiaSky will become the first subcutaneous (SC) injection PNH therapy once a month in the European Union, and patients can inject themselves after adequate training.
This therapy may become an alternative choice for regular intravenous infusion of C5 inhibitors, and is expected to help reduce the burden and life interference of PNH patients and their caregivers.
PNH is a rare and life-threatening syndrome where patients suddenly experience symptoms such as hematuria, anemia, and thrombosis. Currently, there are multiple PNH therapies under clinical trials, and we look forward to these therapies receiving approval to benefit more PNH patients.