Datapoint: Filspari Nabs Full FDA Approval

The FDA on Sept. 5 granted full approval to Travere Therapeutics, Inc.’s Filspari (sparsentan) to slow kidney function decline in adults with primary IgAN who are at risk for disease progression. The agency gave the endothelin and angiotensin II receptor antagonist accelerated approval on Feb. 17, 2023, based on the surrogate marker of proteinuria. Dosing of the tablet starts at 200 mg once daily; after 14 days, dosing increases to 400 mg once daily. Drugs.com lists the price of 30 tablet of both the 200 mg and 400 mg strengths as more than $11,257. Filspari currently holds covered or better status for 74% of all insured lives under the pharmacy benefit, largely with utilization management restrictions applied.

SOURCE: MMIT Analytics, as of 9/16/24

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