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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年隨訪數據顯示,輝瑞的他法米迪將心肌病患者的死亡風險降低了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).

輝瑞(紐約證券交易所市場代碼:PFE)宣佈發表了一項關於Vyndaqel(他法米迪葡胺)/Vyndamax(他法米迪)治療經甲狀腺素澱粉樣心肌病(ATTR-CM)患者的非正式中期分析報告。

  • 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.
  • 該分析來自3期經甲狀腺素澱粉樣心肌病臨牀試驗(ATTR-ACT)。
  • 在長期擴展研究中,服用Vyndaqel 80毫克的患者繼續接受治療,然後過渡到生物等效單膠囊Vyndamax。
  • 在ATTR-ACT試驗中,與安慰劑相比,使用Vyndaqel治療30個月的死亡率降低了30%。
  • 通過近5年的中位隨訪,發表的這項分析顯示,與第一次接受安慰劑治療的患者相比,Vyndaqel/Vyndamax患者的全因死亡風險在臨牀上顯著降低了41%。
  • 持續治療組的中位生存期為67個月,而安慰劑組為35.8個月。
  • 持續治療組的初始五年存活率為53.2%,而安慰劑治療組為32.4%。
  • Vyndaqel/Vyndamax用於治療野生型或遺傳性轉甲狀腺素介導的澱粉樣變性的心肌病,以降低心血管死亡率和心血管相關住院時間。
  • 價格行動:週二尾盤,PFE股價下跌3.75%,至58.72美元。
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