Reported Friday, BridgeBio's Attruby Earns FDA Nod As First Therapy With ≥90% TTR Stabilization, Offering Hope For ATTR-CM Patients
Reported Friday, BridgeBio's Attruby Earns FDA Nod As First Therapy With ≥90% TTR Stabilization, Offering Hope For ATTR-CM Patients
報道稱，BridgeBio的Attruby獲得FDA批准，成爲首個達到≥90% TTR穩定性的治療方案，給ATTR-Cm患者帶來希望。
- Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes
- Attruby demonstrated the most rapid benefit seen in any Phase 3 study of ATTR-CM to date:
- In as few as 3 months, the time to first event (all-cause mortality (ACM) or cardiovascular-related hospitalizations (CVH)) durably separated relative to placebo
- A 42% reduction in composite ACM and recurrent CVH events relative to placebo at Month 30
- A 50% reduction in the cumulative frequency of CVH events relative to placebo at Month 30
- To honor the courage of our U.S. clinical trial participants, BridgeBio will provide these patients Attruby free for life
- To learn about our extensive suite of programs to provide access to Attruby call 1-888-55-BRIDGE (1-888-552-7434)
- With this approval, BridgeBio will receive a $500 million payment under our royalty funding agreement
- Attruby是第一個唯一獲批准並指定幾乎完全穩定TTR的產品。已證明Attruby可以保留TTR作爲甲狀腺素和維生素A的運輸蛋白的天然功能，並對心血管結果有益
- Attruby展示了迄今爲止ATTR-Cm任何3期研究中看到的最快的效益：
- 短短3個月內，首個事件出現的時間（所有原因死亡（ACM）或與心血管相關的住院治療（CVH））相對於安慰劑持久地分開
- 在第30個月，相對於安慰劑，合併的ACm和反覆CVH事件減少42%
- 在第30個月，與安慰劑相比，CVH事件的累積頻率減少50%
- 爲了表彰我們美國臨床試驗參與者的勇氣，BridgeBio將免費爲這些患者提供Attruby，終身免費
- 要了解我們廣泛的計劃套件，以提供獲取Attruby的方式，請撥打1-888-55-BRIDGE (1-888-552-7434)
- 憑藉此批准，BridgeBio將根據我們的知識產權資金協議收到50000萬美元的支付
譯文內容由第三人軟體翻譯。
以上內容僅用作資訊或教育之目的，不構成與富途相關的任何投資建議。富途竭力但無法保證上述全部內容的真實性、準確性和原創性。
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