Ultomiris approved in the EU for children and adolescents with paroxysmal nocturnal haemoglobinuria
Approval based on interim results from Phase III trial demonstrating complete terminal complement inhibition with reduced dosing frequency compared to SolirisUltomiris (ravulizumab) has been approved in the European Union for expanded use to include children (with a body weight of 10 kg or above) and adolescents with paroxysmal nocturnal haemoglobinuria (PNH), an ultra-rare and severe blood disorder characterised by the destruction of red blood cells that can cause thrombosis (blood clots) and result in organ damage and potentially premature death. [1-4] The approval by the European