FDA Declines Travere’s Second Attempt at Accelerated Approval for Sparsentan

FDA Declines Travere’s Second Attempt at Accelerated Approval for Sparsentan

The FDA has rejected Travere Therapeutics’ application for accelerated approval of its investigational drug sparsentan for treatment of patients with focal segmental glomerulosclerosis, a rare disease that affects the kidneys.

This is the second time the agency has denied the company’s request for accelerated approval of this specific drug. The first rejection occurred in May 2021.

The initial rejection was because of inadequate interim data from a phase 3 study. This time around, even with the additional data, the FDA said the data was not enough to support an accelerated approval.

However, the FDA recommended that the company pursue a regular approval pathway for the drug. The company plans to submit a New Drug Application for this indication in the second half of 2023.

About Travere Therapeutics

Travere Therapeutics Inc, formerly Retrophin Inc, is a biopharmaceutical company that discovers, develops, acquires, and markets drugs for the treatment of rare diseases. The company’s products include thiola, chenodal and cholbam. It develops drugs for therapies to people living with rare kidney, liver, and metabolic diseases. Travere Therapeutics pipeline products include sparsentan, used for the treatment of focal segmental glomerulosclerosis; RE-024, a product candidate to treat pantothenate kinase-associated neurodegeneration and RE-034, utilized for the treatment of severe rare diseases. The company markets its products through its distribution partners. It works in partnership with academia and independent researchers to support the development of novel solutions. Travere Therapeutics is headquartered in San Diego, California, the US.

August 8, 2022

https://www.fdanews.com/

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