Tag Archive for: IgA Nephropathy

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 regulator’s website showed on Wednesday.

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.

Topline data from the Phase III APPLAUSE-IgAN study showed that Novartis’ investigational complement inhibitor iptacopan met its pre-specified interim analysis primary endpoint, the company announced 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.