FDA Approves Ionis Pharmaceuticals' Rare Genetic Disease Therapy to Lower High-Level Of Fat In Blood

Benzinga12-20

On Thursday, the FDA approved Ionis Pharmaceuticals, Inc.’s (NASDAQ:IONS) Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a ...

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overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nFDA Approves Ionis Pharmaceuticals' Rare Genetic Disease Therapy to Lower High-Level Of Fat In Blood\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-12-20 20:24 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://finance.yahoo.com/news/fda-approves-ionis-pharmaceuticals-rare-122443485.html><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>On Thursday, the FDA approved Ionis Pharmaceuticals, Inc.’s (NASDAQ:IONS) Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a ...</p>\n\n<a href=\"https://finance.yahoo.com/news/fda-approves-ionis-pharmaceuticals-rare-122443485.html\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"IONS","symbol_name":"Ionis Pharmaceuticals, Inc","start_time":0,"source_url":"https://finance.yahoo.com/news/fda-approves-ionis-pharmaceuticals-rare-122443485.html","article_id":"2492178264","we_media_id":null,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/O8ruVFTE_OfGE.Eo_ZUo9w--~B/aD01NTM7dz05ODM7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/Benzinga/37254c50c996995ed7a1daeeedfee753"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2492178264","pubTimestamp":1734697483,"columns":[],"sourceInfo":{"source_id":"yahoofinance","name":"雅虎金融"},"weMediaInfo":null,"summary":"SHTG isa condition where the level of triglycerides  in the blood is more than three times the normal level.The FDA approval was based on Phase 3 Balance trial data in adult patients.In the Balance study, Tryngolza 80 mg demonstrated a statistically significant placebo-adjusted mean reduction in triglyceride levels of 42.5% from baseline to six months .Reductions from baseline to 12 months were further improved, with Tryngolza achieving a placebo-adjusted 57% mean triglyceride reduction.Tryngolza also demonstrated a substantial, clinically meaningful reduction in AP events over 12 months; one patient (5%) experienced one episode of AP in the Tryngolza group compared with seven patients (30%) who experienced 11 total episodes of AP in the placebo group.Tryngolza will be available in the U.S. before year end.In November, Ionis Pharmaceuticals announced the pivotal Phase 3 study design following alignment with the FDA on ION582 for Angelman syndrome . The trial is expected to start in the","collect":0,"end_time":0,"defaultTopTitle":"yahoo.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"IONS":"Ionis Pharmaceuticals, Inc","BK4006":"钢铁","BK4202":"服装、服饰与奢侈品","GENE":"基因技术ADR","AP":"安博科-匹兹堡","AS":"亚玛芬体育","BK4121":"生命科学工具和服务","BK4139":"生物科技"},"translate_title":"FDA批准Ionis Pharmaceuticals罕见遗传病疗法降低血液中高水平脂肪","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"AP":1,"AS":1,"GENE":1,"IONS":1},"content_text":"On Thursday, the FDA approved Ionis Pharmaceuticals, Inc.’s (NASDAQ:IONS) Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare, genetic form of severe hypertriglyceridemia (SHTG) that can lead to acute pancreatitis (AP).\nSHTG is a condition where the level of triglycerides (type of fat) in the blood is more than three times the normal level. \nTryngolza is the first-ever FDA-approved treatment that significantly and substantially reduces triglyceride levels in adults with FCS and provides a clinically meaningful reduction in AP events when used with an appropriate diet (≤20 grams of fat per day).\nTryngolza is self-administered via an auto-injector once-monthly.\nThe FDA approval was based on Phase 3 Balance trial data in adult patients.\nIn the Balance study, Tryngolza 80 mg demonstrated a statistically significant placebo-adjusted mean reduction in triglyceride levels of 42.5% from baseline to six months (p=0.0084). \nReductions from baseline to 12 months were further improved, with Tryngolza achieving a placebo-adjusted 57% mean triglyceride reduction. \nTryngolza also demonstrated a substantial, clinically meaningful reduction in AP events over 12 months; one patient (5%) experienced one episode of AP in the Tryngolza group compared with seven patients (30%) who experienced 11 total episodes of AP in the placebo group. \nTryngolza will be available in the U.S. before year end.\nOlezarsen is currently being evaluated in three Phase 3 clinical trials – CORE, CORE2, and ESSENCE – for SHTG. Olezarsen has not been reviewed or approved for SHTG.\nIn November, Ionis Pharmaceuticals announced the pivotal Phase 3 study design following alignment with the FDA on ION582 for Angelman syndrome (AS). The trial is expected to start in the first half of 2025.\nAS typically presents in infancy and is characterized by profound intellectual disability, impaired verbal abilities, and severe motor impairment.\nPrice Action: At last check on Friday, IONS stock was up 3.79% at $36.94 during the premarket session.\nRead Next:\n\nMerck’s Investigational Two-Drug Regime For HIV Meets Primary Goal In Two Late-Stage Trials\n\nUp Next: Transform your trading with Benzinga Edge's one-of-a-kind market trade ideas and tools. Click now to access unique insights that can set you ahead in today's competitive market.\nGet the latest stock analysis from Benzinga?\n\nThis article FDA Approves Ionis Pharmaceuticals' Rare Genetic Disease Therapy to Lower High-Level Of Fat In Blood originally appeared on Benzinga.com\n© 2024 Benzinga.com. Benzinga does not provide investment advice. 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