Pfizer Says FDA Accepts Regulatory Submissions For Review Of Tafamidis


(RTTNews.com) - Pfizer Inc. ( PFE ) said that the US Food and Drug Administration accepted for filing the company's New Drug Applications or NDAs for tafamidis for the treatment of transthyretin amyloid cardiomyopathy or ATTR-CM. Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid.

Tafamidis is the only product to complete a Phase 3 trial evaluating its efficacy, safety, and tolerability in patients with ATTR-CM, a rare, fatal, and underdiagnosed condition.

The tafamidis meglumine form (20 mg capsule) has been granted Priority Review. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is in July 2019.

The tafamidis free acid form (61 mg capsule) will be under 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. The target PDUFA action date for a decision by the FDA is in November 2019.


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