3 September 2021 - Approval based on interim results from Phase 3 trial demonstrating complete terminal complement inhibition with reduced dosing frequency compared to Soliris.

Ultomiris (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, an ultra-rare and severe blood disorder characterised by the destruction of red blood cells that can cause thrombosis and result in organ damage and potentially premature death.

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