By Michael Susin

AstraZeneca PLC said Monday that its treatment for patients with neuromyelitis optica spectrum disorder has been recommended for marketing authorization in the European Union.

The pharma giant said Ultomiris has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use based on Phase 3 trial results.

The company said Ultomiris, which is designed for patients with neuromyelitis optica spectrum disorder who are anti-aquaporin-4 antibody positive, has met its primary endpoint.

If authorized, the treatment would be the first and only approved long-acting complement inhibitor for the treatment in the European Union.

The company's regulatory submissions for Ultomiris are also currently under review with multiple health authorities, including in the U.S. and Japan.

Write to Michael Susin at michael.susin@wsj.com

(END) Dow Jones Newswires

April 03, 2023 02:33 ET (06:33 GMT)

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