09:57 AM EDT, 06/05/2024 (MT Newswires) -- Amgen ( AMGN ) said Wednesday its phase 3 clinical trial evaluating Uplizna as a treatment for immunoglobulin G4-related disease, an autoimmune condition, met its primary and key secondary endpoints.

The company said treatment with Uplizna showed an 87% reduction in the risk of IgG4-RD flares, which was the study's primary endpoint. The secondary endpoints of annualized flare rate, flare-free, treatment-free complete remission, and flare-free corticosteroid-free complete remission were also met, the company added.

No new safety issues were found, and the safety profile remained consistent with known data on Uplizna, according to Amgen ( AMGN ).

The company said it plans to seek US approval based on these trial results, followed by filings in other key markets.

Uplizna is currently approved for neuromyelitis optica spectrum disorder by multiple regulatory agencies, including the US Food and Drug Administration, Amgen ( AMGN ) said.

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