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Thursday, November 12, 2020

Pfizer's tafamidis extends survival in patients with rare heart failure condition

  • Following up on its initial announcement in March 2018, Pfizer (PFE -2.5%) releases additional data from a Phase 3 clinical trial, ATTR-ACT, evaluating Vyndaqel (tafamidis meglumine) 80mg/Vyndamax (tafamidis) 61 mg in patients with a subtype of transthyretin amyloidosis (ATTR) called ATTR cardiomyopathy (ATTR-CM).
  • Per the first report, the study met the primary endpoint demonstrating a statistically significant reduction in the combination all-cause mortality and frequency of cardiovascular (CV)-related hospitalizations at month 30 compared to placebo. The relative risk reductions in all-cause mortality and CV-related hospitalizations were 30% and 32%, respectively.
  • A long-term extension study is ongoing with an estimated completion date in December 2026.
  • The FDA approved the transthyretin stabilizer in May 2019 for ATTR-CM.
  • https://seekingalpha.com/news/3635634-pfizers-tafamidis-extends-survival-in-patients-rare-heart-failure-condition

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