Pfizer Wins Tafamidis Approval; Now It Will Need To Build The Market
Tafamidis was approved by FDA in two formulations that will be marketed as Vyndaqel and Vyndamax for the treatment of transthyretin amyloid cardiomyopathy.
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ATTR amyloidosis patients with cardiomyopathy had statistically significant functional and quality of life improvements when treated with Onpattro (patisiran) in the Phase III APOLLO-B study.
The company intends to use the series B cash to bring the first of its pan-amyloid removal (PAR) therapies into the clinic, while also advancing a diagnostic tool for systemic amyloidosis.
The drug outperformed investor expectations, generating $79m in the US in its first full quarter on the market, after Pfizer had set low expectations for the initial launch.