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# 2 Pfizer NDAs Accepted for Tafamidis
- URL: https://www.fdaweb.com/2-pfizer-ndas-accepted-for-tafamidis/
- Published: 2019-01-14T12:00:00.000Z
- Updated: 2026-09-15T00:54:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143142

FDA has accepted for review two Pfizer NDAs for tafamidis for treating transthyretin amyloid cardiomyopathy (ATTR-CM). The submission are based on two formulations of tafamidis — meglumine salt and free acid. The company says the tafamidis meglumine form (20 mg capsule) has been granted a priority review with a user fee review action target date in July. The tafamidis free acid form (61 mg capsule) will be under a standard review. “This form is bioequivalent to the 80 mg tafamidis meglumine dose, which was administered as four 20 mg capsules in the pivotal trial; it was developed for patient convenience to enable a single capsule for daily administration,” Pfizer says. The user fee review action for this submission is expected in November.

The submissions are based on findings from the pivotal Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study, which evaluated the efficacy, safety, and tolerability of tafamidis meglumine compared to placebo for treating patients with ATTR-CM. Pfizer says tafamidis met the primary endpoint, “demonstrating a significant reduction in the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo over a 30-month period in patients with wild-type or hereditary ATTR-CM.” It says the drug was well tolerated, with an observed safety profile comparable to placebo.