By Siddhi Mahatole and Sahil Pandey
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, sending its shares nearly 20% down in afternoon trade.
The agency will now give its decision on April 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.
The extension comes a day after the company said it has responded to the FDA’s request for more data on the clinical benefit of the drug.
No additional information relating to the safety or manufacturing of the drug has been requested, Travere said on Tuesday.
“We remain focused on the goal of bringing Filspari to the patients who urgently need an effective medicine for this devastating and rapidly progressing disease and remain committed to working with the Agency during the extension period,” CEO Eric Dube said.
Sparsentan, under the brand name Filspari, is already approved to slow kidney function decline in adults with IgA nephropathy, a progressive autoimmune condition.
In a late-stage study of patients with FSGS, 37.5% of those treated with Sparsentan lowered protein levels in urine compared with 21.4% of those receiving another kidney disease drug, irbesartan.
Sparsentan protects kidney cells by blocking two key receptors, helping to reduce protein leakage and slow disease progression.
“Sparsentan reduces proteinuria, but it did not clearly slow the loss of kidney function as measured by the slope of GFR change,” said John Sperati, associate professor at the Johns Hopkins University School of Medicine.
Swiss drugmaker Novartis is also testing its drug, atrasentan, in a mid-stage trial for patients with FSGS.
(Reporting by Sahil Pandey and Siddhi Mahatole in Bengaluru; Editing by Sahal Muhammed)
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