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

Ref: Pfizer | Image: Pfizercentreone