U.S. FDA approves Travere Therapeutics kidney disorder drug

[February 18, 2023]  By Sriparna Roy, Nandhini Srinivasan and Khushi Mandowara

(Reuters) -Travere Therapeutics said on Friday the U.S. health regulator has granted accelerated approval to its drug to treat a type of chronic kidney disease, IgAN, in adults with a high risk of advancing to kidney failure.

Shares of the drugmaker were up 2.8% at $18.32 after market

The drug, with the brand name Filspari, comes with a boxed warning for inflammation in liver and birth defects. Patients will need to be tested for liver toxicity before starting the drug.

During the treatment, patients would be profiled for toxicity data on a monthly frequency for the first 12 months, and then once in every three months.

The approval pits Filspari against Calliditas Therapeutics' Tarpeyo, which was greenlit by the U.S. Food and Drug Administration in December 2021.

Filspari will be priced at $9,900 per month, making it cheaper than Tarpeyo's cost of $14,160 per month or $170,000 a year. At least three analysts expected the list price of Travere's drug to be between $70,000 and $100,000 a year.

Jefferies analyst Maury Raycroft estimates that for the year, Travere could make about $35 million in 2023 from sales of the kidney drug. It is expected to have peak sales of $745 million in the United States.

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly

Travere expects to launch the drug by end of the month through its specialty distributors and specialty pharmacies in the United States.

IgA nephropathy (IgAN), also called Berger's disease, occurs when immunoglobulin A antibodies, proteins made by the immune system to protect the body, build up in the kidneys, damaging tissues and leaking blood and protein into urine.

The tissue damage affects the filtering ability of the kidneys, and eventually progresses to end-stage kidney failure. Analysts estimate that about 150,000 patients suffer from this condition in the U.S.

(Reporting by Sriparna Roy, Khushi Mandowara and Nandhini Srinivasan in Bengaluru; Editing by Krishna Chandra Eluri)

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