FDA Eases Monitoring Burden For Kidney Disease Patients On Travere Therapeutics' Filspari

Benzinga_recent_news08-29

The U.S. Food and Drug Administration (FDA) on Wednesday approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for Travere Therapeutics, Inc.’s TVTX Filspari (sparsentan), the only ...

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It removes the embryo-fetal toxicity (EFT) monitoring requirement from the REMS.\nThe reduction of Filspari liver monitoring REMS from monthly to every three months from the onset of treatment was supported by safety data from post-marketing surveillance as well as the Phase 3 PROTECT Study in IgAN, the Phase 3 DUPLEX Study, and the Phase 2 DUET Study in focal segmental glomerulosclerosis (FSGS).\nAlso Read: Kidney Disease-Focused Vera Therapeutics Concludes Enrollment In Pivotal Study, Targets 2026 Commercial Launch\nThe FDA determined that the REMS requirement for EFT for Filspari was no longer necessary following an analysis of human pregnancy data compiled from the use of ERA medicines from the last two decades.\nA supplemental New Drug Application for Filspari in FSGS is currently under review with the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026.\nIf approved, Filspari would be the first and only approved medicine indicated for FSGS.\nOn Wednesday, Vor Bio Inc. VOR announced that its collaborator, RemeGen Co., Ltd., achieved the primary endpoint in Stage A of a Phase 3 clinical study in China evaluating telitacicept in adults with IgAN.\nIn Stage A of the Phase 3 study, telitacicept achieved the primary endpoint of reducing proteinuria, demonstrating a 55% reduction in 24-hour urine protein-to-creatinine ratio (UPCR) at 39 weeks compared with placebo.\nIn April, the U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval for Novartis AG's NVS Vanrafia (atrasentan) to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression.\nVanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase 3 ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo.\nTVTX Price Action: Travere Therapeutics stock is up 7.11% at $18.68 at the last check on Thursday\nRead Next:\nPhoto: Shutterstock","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.35.12","shortVersion":"4.35.12","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2563057684","isCrawlerRequest":true}