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US FDA ACCEPTS REGULATORY SUBMISSIONS FOR REVIEW OF TAFAMIDIS TO TREAT TRANSTHYRETIN AMYLOID CARDIOMYOPATHY

US FDA ACCEPTS REGULATORY SUBMISSIONS FOR REVIEW OF TAFAMIDIS TO TREAT TRANSTHYRETIN AMYLOID CARDIOMYOPATHY

Monday, January 14, 2019 – 8:00am

EST

Pfizer Inc. (NYSE: PFE) announced today that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (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.

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