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

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