AstraZeneca drug Ultomiris approved for use on children in EU

(Alliance News) - AstraZeneca PLC on Friday said the EU approved its severe blood disorder drug ...

Alliance News 3 September, 2021 | 8:13AM
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(Alliance News) - AstraZeneca PLC on Friday said the EU approved its severe blood disorder drug for use in children.

The coronavirus jab maker developed drug Ultomiris to treat paroxysmal nocturnal haemoglobinuria, a severe blood disorder that destroys red blood cells, leading to blood clots, organ damage and sometimes premature death.

The recent EU approval means the drug can be used to treat children with a body weight of 10 kilogrammes or above and adolescents.

The European Commission based the approval on positive interim results from AstraZeneca's Phase III clinical trial in children and adolescents with paroxysmal nocturnal haemoglobinuria.

"Ultomiris had no reported treatment-related severe adverse events, and no patients discontinued treatment during the primary evaluation period," the biopharmaceutical firm said.

Phase III results showed the drug was "effective in achieving complete C5 complement inhibition through 26 weeks for the treatment of patients up to 18 years of age" who have the ultra-rare blood disorder.

Ultomiris was recommended for child approval by The Committee for Medicinal Products for Human Use of the European Medicines Agency back in July.

"Ultomiris provides an advancement for paediatric patients in the EU with an established safety and efficacy profile," commented King's College Hospital blood doctor Austin Kulasekararaj.

"By requiring fewer infusions each year than Soliris, Ultomiris may reduce the need for these young patients to miss school to receive treatment."

Shares in AstraZeneca opened 0.5% higher at 8,655.00 pence in London on Friday.

By Josie O'Brien; josieobrien@alliancenews.com

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