Roche announced that the European Commission has approved crovalimab – a novel recycling monoclonal antibody that inhibits the complement protein C5 – for use in adults and adolescents (aged 12 years and older and weighing 40 kg or more) with paroxysmal nocturnal haemoglobinuria (PNH), regardless of whether they have been previously treated with C5 inhibitors. PNH is a rare, life-threatening blood disorder in which red blood cells are destroyed by the complement system – part of the innate immune system – leading to symptoms such as anaemia, fatigue and blood clots, and potentially leading to kidney disease.
Crovalimab – reports a note from Roche – is the first monthly subcutaneous treatment for PNH available in the EU, with the possibility of self-administration (subject to appropriate training). It provides an alternative option to current C5 inhibitors – which require periodic intravenous infusions – which could help reduce the treatment burden and daily discomfort for people with PNH and their caregivers.
“The approval of crovalimab introduces a new treatment option for PNH, combining the disease control achieved through C5 inhibition with a cutting-edge recycling technology that allows for monthly subcutaneous dosing,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “We are pleased to offer this new treatment to people with PNH in Europe, in the hope that it will reduce the burden of care faced by many living with this disease.”
The approval – the note details – is based on the results of the phase III COMMODORE 2 study, conducted in people with PNH who had not previously been treated with C5 inhibitors. The study showed that crovalimab, administered as a subcutaneous injection every four weeks, achieved disease control and was well tolerated. Crovalimab was shown to be non-inferior – and with comparable safety – to eculizumab (a current standard of care C5 inhibitor) administered intravenously every two weeks. The rate of adverse events in people treated with crovalimab was similar to that of treatment with eculizumab.
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