Reported Friday, BridgeBio's Attruby Earns FDA Nod As First Therapy With ≥90% TTR Stabilization, Offering Hope For ATTR-CM Patients

报道称，BridgeBio的Attruby获得FDA批准，成为首个达到≥90% TTR稳定性的治疗方案，给ATTR-Cm患者带来希望。

Benzinga · 2024/11/25 01:31

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是第一个唯一获批准并指定几乎完全稳定TTR的产品。已证明Attruby可以保留TTR作为甲状腺素和维生素A的运输蛋白的天然功能，并对心血管结果有益
Attruby展示了迄今为止ATTR-Cm任何3期研究中看到的最快的效益：
短短3个月内，首个事件出现的时间（所有原因死亡（ACM）或与心血管相关的住院治疗（CVH））相对于安慰剂持久地分开
在第30个月，相对于安慰剂，合并的ACm和反复CVH事件减少42%
在第30个月，与安慰剂相比，CVH事件的累积频率减少50%
为了表彰我们美国临床试验参与者的勇气，BridgeBio将免费为这些患者提供Attruby，终身免费
要了解我们广泛的计划套件，以提供获取Attruby的方式，请拨打1-888-55-BRIDGE (1-888-552-7434)
凭借此批准，BridgeBio将根据我们的知识产权资金协议收到50000万美元的支付

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