US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
(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. "By removing or depleting these B cells throughout the body, both in the circulating blood and in the tissue, there's a chance for Uplizna to confer a real benefit," said Jay Bradner, Amgen's head of research and development.