LONDON (dpa-AFX) - AstraZeneca PLC (AZN.L) announced Ultomiris has been approved in the European Union for expanded use to include children and adolescents with paroxysmal nocturnal haemoglobinuria. The approval by the European Commission was based on interim results from the phase III clinical trial, the company said.
Ultomiris was previously approved in the EU for the treatment of adults with paroxysmal nocturnal haemoglobinuria and is also approved for the treatment of adults and children with atypical haemolytic uraemic syndrome.
Marc Dunoyer, CEO, Alexion, said: 'Ultomiris has become the standard of care for the treatment of adults with PNH and we will make it available to this younger patient population as soon as possible.'
Copyright RTT News/dpa-AFX
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