Amgen's Uplizna Hits Phase 3 Endpoints in IgG4-RD

By Colin Kellaher

Amgen on Wednesday said a late-stage study of its autoimmune drug Uplizna hit its key goals in the treatment of immunoglobulin G4-related disease, a chronic, immune-mediated disease known as IgG4-RD.

Amgen said the Phase 3 study met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo, as well as key secondary endpoints.

The Thousand Oaks, Calif., biotechnology company said it plans to seek U.S. Food and Drug Administration approval of Uplizna in IgG4-RD, followed by other key markets.

Uplizna is currently approved in the U.S., Europe and several other countries for the rare autoimmune disease neuromyelitis optica spectrum disorder.

Amgen acquired Uplizna as part of its $27.8 billion acquisition of Horizon Therapeutics last year.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

06-05-24 0943ET