FDA Approves Second Indication for Amgen's Immune System Treatment Uplizna

Dow Jones

2025/04/04

By Josh Beckerman

Amgen said the Food and Drug Administration approved Uplizna for Immunoglobulin G4-related disease, the second approved indication.

The biotechnology company said Thursday the FDA granted breakthrough therapy designation.

In 2020, the FDA approved Uplizna for AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder.

Amgen is also working toward approval for generalized myasthenia gravis.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

April 03, 2025 16:10 ET (20:10 GMT)

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