By Sabela Ojea

AstraZeneca PLC said Monday that its Ultomiris drug has been recommended for marketing authorization in the European Union by the EMA Committee for Medicinal Products for Human Use, or CHMP.

The pharmaceutical major said the use of the drug has been expanded to include children and adolescents with paroxysmal nocturnal haemoglobinuria.

The opinion is based on results from an Ultomiris phase 3 trial, which showed an established efficacy and safety profile with reduced treatment burden for children with PNH and their families, the FTSE 100 listed company added.

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

(END) Dow Jones Newswires

July 26, 2021 02:27 ET (06:27 GMT)

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