FDA nod sets up Pfizer's Vyndaqel for blockbuster status

7 May 2019

Pfizer’s (NYSE: PFE) Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) look good for exceeding the $1 billion blockbuster threshold.

The capsules were approved on Monday by the US Food and Drug Administration (FDA) for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults.

There was previously no FDA-approved drug in this rare, life-threatening disease characterized by the build-up of abnormal deposits of misfolded protein called amyloid in the heart and is defined by restrictive cardiomyopathy and progressive heart failure. Its prevalence has been estimated at around 100,000 cases in the USA.

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