Olezarsen Achieves Up to 72% Triglyceride Reduction in Phase 3 sHTG Trials

Reuters
2025/11/08
Olezarsen Achieves Up to 72% Triglyceride Reduction in Phase 3 sHTG Trials

Swedish Orphan Biovitrum AB (Sobi) has announced positive results from the pivotal Phase 3 CORE and CORE2 studies evaluating olezarsen in patients with severe hypertriglyceridemia (sHTG). The results were presented as a late breaker at the American Heart Association 2025 Scientific Sessions. The studies achieved the primary endpoint, with olezarsen demonstrating a placebo-adjusted mean reduction in fasting triglyceride levels of up to 72% at six months, with reductions sustained through 12 months. Nearly 1,100 patients participated in the trials, which required standard of care lipid-lowering therapy. Olezarsen showed a favorable safety and tolerability profile, with adverse and serious adverse events balanced or less frequent compared to placebo. An open-label extension study is ongoing, and Sobi plans to submit a marketing authorization application for olezarsen in mixed chylomicronemia syndrome $(MCS)$ to the EMA in 2026, while its partner Ionis intends to submit a supplemental new drug application for sHTG to the FDA by the end of this year.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Swedish Orphan Biovitrum AB published the original content used to generate this news brief on November 08, 2025, and is solely responsible for the information contained therein.

應版權方要求,你需要登入查看該內容

免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。

熱議股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10