enforcement

Travere’s Filspari Promotion Overstates Kidney Benefits: FDA

FDA has cited Travere Therapeutics over promotional materials for Filspari (sparsentan) because they contain misleading claims about the drug’s ability to preserve kidney function and its safety profile.

“Specifically, claims suggesting that patients treated with Filspari will achieve kidney preservation, preservation of kidney function, or nephroprotection are misleading because these outcomes have not been demonstrated, CDER Office of Prescription Drug Promotion (OPDP) said in a just-posted letter. “The FDA-approved prescribing information (PI) states that Filspari ‘is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression.’” FDA noted that patients receiving Filspari continued to experience a decline in kidney function during the clinical study period.

The OPDP letter also challenged claims that Filspari had been “proven” to produce complete remission of proteinuria at three times the rate of another treatment. The agency said complete remission of proteinuria was assessed as an exploratory endpoint rather than a confirmatory endpoint.

Because no statistical significance threshold, or alpha level, had been prespecified for that analysis, FDA said it could not be determined whether the finding reflected an effect of Filspari or occurred by chance. As a result, the agency said the exploratory data did not support claims that Filspari was proven to drive complete remission.

Additionally, FDA objected to safety-related messaging in the promotional material, particularly the statement that Filspari was “well tolerated over two years.” The letter said the statement minimized significant risks identified in Filspari’s prescribing information. The drug carries Boxed Warnings for hepatotoxicity and embryo-fetal toxicity. Because of the liver-related risk, Filspari is available only through a restricted Risk Evaluation and Mitigation Strategy.

The promotional material also stated, “No drug-induced liver injury following treatment with Filspari.” The FDA said this presentation was misleading because cases of drug-induced liver injury involving hepatocellular damage had occurred. Patients taking Filspari therefore require regular liver monitoring.

In April, FDA granted full approval for Filspari for treating patients with Focal Segmental Glomerulosclerosis, marking the first approved medicine specifically for the rare kidney disorder. Sparsentan is described as a first-in-class medication used to slow kidney function decline in adults with primary immunoglobulin A nephropathy who are at risk of rapid disease progression. It was granted full FDA approval for that indication 9/2024 after previously receiving accelerated approval 2/2023.

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