Health
Amgen Wins FDA Nod for Uplizna to Treat Rare Disease
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US regulators approved Amgen Inc.’s Uplizna as the first and only treatment for a rare inflammatory condition that causes tumor-like growths in organs.
Uplizna was first approved in 2020 to treat another rare disease that affects the optic nerve and spinal cord. On Thursday, the US Food and Drug Administration cleared it for immunoglobulin G4-related disease, or IgG4-RD, after the treatment received Breakthrough Therapy designation to expedite the approval process.