Amgen (AMGN) said Friday the US Food and Drug Administration approved Uplizna as treatment for adults with immunoglobulin G4-related disease, a chronic immune-mediated inflammatory condition that can damage multiple organs.
The company said the FDA's decision was supported by results from a randomized double-blind trial, which showed the drug significantly lowered the risk of disease flares compared with placebo, the company said.
This is the second approved indication for Uplizna, which was already approved for the treatment of neuromyelitis optica spectrum disorder, Amgen said.
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