Jan 13 (Reuters) – The U.S. Food and Drug Administration has extended its review for the expanded use of Travere Therapeutics’ drug to treat a type of rare kidney disorder, the drugmaker said on Tuesday.
The agency will now give its decision on April 13, compared to its previous action date of January 13.
Travere’s drug, Sparsentan, was being tested in patients with focal segmental glomerulosclerosis (FSGS), a kidney disease that scars parts of the filtering units, leading to protein in the urine, swelling and possible kidney failure.
Sparsentan, under the brand name, Filspari, is already approved to slow kidney function decline in adults with IgA nephropathy, a progressive autoimmune condition.
(Reporting by Sahil Pandey and Siddhi Mahatole in Bengaluru; Editing by Sahal Muhammed)
