(Reuters) -The U.S. Food and Drug Administration has approved expanded use of Amgen’s drug, Uplizna, to help reduce the risk of flares in patients with a rare immune system-related condition, the regulator said on Thursday.
The drug, also known as inebilizumab, has now become the first FDA-approved treatment for Immunoglobulin G4-related disease (IgG4-RD), a rare condition in which an overactive immune system can lead to inflammation and scarring in various organs, including the pancreas, liver and kidneys.
Uplizna, given by infusion, is designed to bind to a protein located on the surface of B cells, the underlying inflammatory cause of IgG4-RD and other autoimmune conditions.
The approval was based on data from a late-stage study in which Uplizna helped reduce the risk of flares by 87% compared to a placebo.
The drug improved the chances of complete remission without flares in a year, the company said.
Uplizna has already been approved in the U.S. for a rare, severe neuroinflammatory disease called neuromyelitis optica spectrum disorder.
(Reporting by Siddhi Mahatole, Mariam Sunny and Puyaan Singh in Bengaluru and Deena Beasley in Los Angeles; Editing by Alan Barona)
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