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Five-Year Follow-Up Data Show Pfizer's Tafamidis Cuts Risk of Mortality by 41% In Cardiomyopathy Patients

Five-Year Follow-Up Data Show Pfizer's Tafamidis Cuts Risk of Mortality by 41% In Cardiomyopathy Patients

5年随访数据显示,辉瑞的他法米迪将心肌病患者的死亡风险降低了41%
Benzinga Real-time News ·  2021/12/21 12:52

Pfizer Inc (NYSE:PFE) announced the publication of a post-hoc, interim analysis of Vyndaqel (tafamidis meglumine) / Vyndamax (tafamidis) in patients with transthyretin amyloid cardiomyopathy (ATTR-CM).

辉瑞(纽约证券交易所市场代码:PFE)宣布发表了一项关于Vyndaqel(他法米迪葡胺)/Vyndamax(他法米迪)治疗经甲状腺素淀粉样心肌病(ATTR-CM)患者的非正式中期分析报告。

  • The analysis comes from the Phase 3 Transthyretin Amyloid Cardiomyopathy Clinical Trial (ATTR-ACT).
  • In the long-term extension study, patients treated with Vyndaqel 80 mg continued the therapy, then transitioned to the bioequivalent single-capsule Vyndamax. 
  • In ATTR-ACT, treatment with Vyndaqel demonstrated a 30% reduction in mortality at 30 months compared to placebo. 
  • With a median follow-up of nearly five years, the analysis published showed a clinically significant 41% reduction in the risk of all-cause mortality in Vyndaqel / Vyndamax patients compared to patients who first received placebo.
  • Median survival was 67 months in the continuous treatment arm compared to 35.8 months in the placebo to treatment arm. 
  • The initial five-year survival rate was 53.2% in the continuous treatment arm versus 32.4% in the placebo to treatment arm.
  • Vyndaqel / Vyndamax are indicated for cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis to reduce cardiovascular mortality and cardiovascular-related hospitalization. 
  • Price Action: PFE shares are down 3.75% at $58.72 during the market session on the last check Tuesday.
  • 该分析来自3期经甲状腺素淀粉样心肌病临床试验(ATTR-ACT)。
  • 在长期扩展研究中,服用Vyndaqel 80毫克的患者继续接受治疗,然后过渡到生物等效单胶囊Vyndamax。
  • 在ATTR-ACT试验中,与安慰剂相比,使用Vyndaqel治疗30个月的死亡率降低了30%。
  • 通过近5年的中位随访,发表的这项分析显示,与第一次接受安慰剂治疗的患者相比,Vyndaqel/Vyndamax患者的全因死亡风险在临床上显著降低了41%。
  • 持续治疗组的中位生存期为67个月,而安慰剂组为35.8个月。
  • 持续治疗组的初始五年存活率为53.2%,而安慰剂治疗组为32.4%。
  • Vyndaqel/Vyndamax用于治疗野生型或遗传性转甲状腺素介导的淀粉样变性的心肌病,以降低心血管死亡率和心血管相关住院时间。
  • 价格行动:周二尾盘,PFE股价下跌3.75%,至58.72美元。
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