Pfizer's small molecule tafamidis approved for TTR amyloid cardiomyopathy

FDA approved two forms of Pfizer's tafamidis Monday well ahead of their PDUFA dates, making the therapies the first small molecules approved for the cardiomyopathy dominant form of transthyretin (TTR) amyloidosis in the U.S. The tafamidis products are indicated for the wild-type and hereditary forms of the disease.

The recommended dose of Vyndaqel tafamidis meglumine salt is 80 mg once daily, taken orally as four 20 mg capsules. The free acid form, Vyndamax, contains 61 mg tafamidis in a single capsule and is taken orally once daily. Pfizer Inc. (NYSE:PFE) has said the free acid form is bioequivalent to the meglumine salt form, and was developed for patient convenience...