Posted by Michael Wonder on 26 Jul 2021
Ultomiris recommended for approval in the EU by CHMP for children and adolescents with paroxysmal nocturnal haemoglobinuria
26 July 2021 - Opinion based on results from Ultomiris Phase 3 trial that showed an established efficacy and safety profile with reduced treatment burden for children with paroxysmal nocturnal haemoglobinuria and their families.
Alexion’s Ultomiris (ravulizumab) has been recommended for marketing authorisation in the European Union for expanded use to include children and adolescents with paroxysmal nocturnal haemoglobinuria.
