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The approval was based on data from a late-stage study, which showed that Ozempic helped cut the risk of death from chronic kidney disease and major cardiac events by 24%, the company said.
Finerenone, marketed under the brand name Kerendia among others, is a medication used to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adults with chronic kidney disease associated with type 2 diabetes. [8]
It also reduced the risk of kidney failure and cut the risk of death from heart disease by about 5% in adults with both type 2 diabetes and chronic kidney disease, the company said in a news release.
Sparsentan was approved in the US under accelerated approval based on reduction of proteinuria. [2] [6] [13] In September 2024, the US FDA converted the conditional approval in the kidney disease IgA nephropathy (IgAN) into a full approval based on positive long-term confirmatory results from the PROTECT Study demonstrating that sparsentan significantly slowed kidney function decline over two ...
By Sriparna Roy (Reuters) -The U.S. Food and Drug Administration has approved the use of Novartis' drug to reduce excess protein in the urine of patients with a type of kidney disease, the health ...
Daprodustat was approved for medical use in Japan in June 2020, [5] [6] and in the United States in February 2023. [2] [3] [7] [8] making it the first oral treatment for anemia caused by chronic kidney disease for adults in the US. [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [9]
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