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

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

  • 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.
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