Pfizer’s Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) Receive FDA’s Approval for Transthyretin Amyloid Cardiomyopathy

Pfizer’s Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) Receive FDA’s Approval for Transthyretin Amyloid Cardiomyopathy

Shots:

  • The approval is based on P-III ATTR-ACT study assessing Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) vs PBO in patients with ATTR-CM
  • The P-III ATTR-ACT study results: @30mos. reduction in cardiovascular mortality & frequency of cardiovascular-related hospitalizations (30%, 32%)
  • Vyndaqel (80mg, qd) & Vyndamax (61mg, qd) are oral therapies, targeting transthyretin to stabilize tetramer of the transthyretin transport protein and slowing the formation of amyloid. Vyndaqel has received EU approval for ATTR-PN in 2011, FDA’s, EU’s & Japan’s ODD in 2012 & 2018 respectively

Click here to read full press release/ article | Ref: Pfizer | Image: Pfizercentreone