By Siddhi Mahatole and Unnamalai L
April 13 (Reuters) – The U.S. Food and Drug Administration has approved the expanded use of Travere Therapeutics’ drug to treat a rare kidney disorder, the company said on Monday.
The approval makes Sparsentan the first drug of its kind approved to treat focal segmental glomerulosclerosis (FSGS), a kidney disease that scars parts of the filtering units and can lead to protein in the urine, swelling and kidney failure.
Sparsentan protects kidney cells by blocking two key receptors, helping reduce protein leakage and slowing disease progression.
The decision follows the FDA’s extension of its review in January nL4N3YE1TE to seek more data on the drug’s clinical benefit.
Sparsentan is already approved under the brand name Filspari to slow kidney function decline in adults with IgA nephropathy, a progressive autoimmune condition.
Travere said the drug would be available for nephrologists to immediately prescribe to patients with FSGS.
FSGS is estimated to affect more than 40,000 patients in the U.S., with a similar prevalence in Europe, according to the company.
Travere prices Filspari at $9,900 a month https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-travere-therapeutics-kidney-disorder-drug-2023-02-17/ to treat IgA nephropathy, or about $170,000 a year.
“We think the price should be approximately 2x of what they’re charging for IgAN, and that’s because of the higher dose,” Jefferies analyst Maury Raycroft told Reuters.
Jefferies analysts expect peak sales for the drug to reach $961 million by 2033 for the condition.
Travere obtained rights to the drug from Ligand Pharmaceuticals in 2012 under a licensing agreement that entitles Ligand to milestone payments and a 9% royalty on global sales.
Filspari, approved in 2023 for IgA nephropathy, carries boxed warnings for liver damage and birth defects.
Swiss drugmaker Novartis is also testing its drug, atrasentan, in a mid-stage trial in patients with FSGS.
Filspari generated sales of $103.3 million in the three months ended December 31.
(Reporting by Unnamalai L and Siddhi Mahatole in Bengaluru; Editing by Tasim Zahid, Vijay Kishore and Maju Samuel)
