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US FDA extends review of Travere’s drug for rare kidney disease

- - US FDA extends review of Travere’s drug for rare kidney disease

ReutersJanuary 14, 2026 at 2:37 AM

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FILE PHOTO: A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo

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)

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