Summary
- Pfizer announced that it had submitted both NDA applications to receive FDA approval for tafamidis to treat patients with transthyretin amyloid cardiomyopathy.
- The priority review designation was based on outstanding data in which tafamidis showed reductions of all-cause mortality and frequency of cardiovascular-related hospitalizations in a 30-month period.
- Alnylam and Ionis are two other competitors that have already received FDA approval for their drugs treating TTR amyloidosis.
- The meglumine form of tafamidis has a PDUFA date of July 2019, while the free acid form won't be reviewed until November of 2019.
- An analyst estimates that the tafamidis program could add 4% to the EPS of Pfizer.
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Recently, Pfizer (PFE) announced that it had successfully submitted both its New Drug Applications (NDA) for tafamidis. The two applications are for each version of the drug being approved to treat patients with a rare disease known as transthyretin amyloid cardiomyopathy (ATTR-CM). Based on highly positive data from a phase 3 study, the FDA had chosen to make a decision on the drug with a priority review status for one version of tafamidis. This is a huge positive for the drug because it will be reviewed at an earlier period.
