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The drug, with the brand name Filspari, comes with a boxed warning for inflammation in liver and birth defects.
The approval pits Filspari against Calliditas Therapeutics’ Tarpeyo, which was greenlit by the U.S. Food and Drug Administration in December 2021.
IgA nephropathy (IgAN), also called Berger’s disease, occurs when immunoglobulin A antibodies, proteins made by the immune system to protect the body, build up in the kidneys, damaging tissues and leaking blood and protein into urine.
The tissue damage affects the filtering ability of the kidneys, and eventually progresses to end-stage kidney failure. Analysts estimate that about 150,000 patients suffer from this condition in the U.S.
