Posted by Michael Wonder on 07 Jun 2021
Alexion announces FDA approval of Ultomiris (ravulizumab-cwvz) for children and adolescents with paroxysmal nocturnal haemoglobinuria
7 June 2021 - Approval based on interim results from Phase 3 study showing Ultomiris demonstrated complete terminal complement inhibition through 26 weeks.
Alexion Pharmaceuticals today announced the U.S. FDA has approved the expanded use of Ultomiris (ravulizumab-cwvz) to include children (one month of age and older) and adolescents with paroxysmal nocturnal haemoglobinuria.
