Merck’s experimental drug efinopegdutide, which belongs to the GLP-1 class and is being developed as a treatment for non-alcoholic steatohepatitis (NASH), also showed a “compelling” weight-loss benefit.
Tag Archive for: kidney disease
DefenCath, a combination of the antimicrobial active ingredient taurolidine and blood thinner heparin, has previously been rejected twice by the U.S. Food and Drug Administration (FDA) on manufacturing concerns.
Following two late-stage failures, Travere Therapeutics has unveiled the results of two Phase III studies, attempting to regain Filspari’s footing in IgA nephropathy and focal segmental glomerulosclerosis.
Treatment with the drug candidate, acquired as part of the purchase of U.S. biotech firm Chinook for up to $3.5 billion, resulted in a meaningful improvement in proteinuria in patients suffering from IgA nephropathy when compared to placebo, the Swiss drugmaker said in a statement.
Today the company announced it will discontinue a trial studying its experimental therapy to treat a type of kidney disease after it failed to meet the main goal of the late-stage study.
Novo Nordisk has agreed to buy ocedurenone, a drug for uncontrolled hypertension with potential application in cardiovascular and kidney disease, from KBP Biosciences for up to $1.3 billion, the Danish drugmaker said on Monday.
Chinook has a leading compound designed to treat IgA Nephropathy, or IgAN, a rare disease that can lead to kidney failure in young adults which has attracted a range of developers and is already the target of drug candidate developed by Novartis.
The miss is the latest setback for the company whose application seeking approval for the drug to treat anemia in kidney disease patients was rejected by the U.S. Food and Drug Administration in 2021 seeking additional data.
The FDA is investigating the risk of severe hypocalcemia with serious outcomes, including hospitalization and death, in patients with advanced kidney disease on dialysis treated with the osteoporosis medicine Prolia (denosumab).
FDA staff reviewers raised concerns over unclear benefits of Ardelyx Inc.’s drug for kidney disease patients, stating, “the magnitude of treatment effect appears less than that observed with approved drugs,” in briefing documents released on Monday.