Posted by Michael Wonder on 14 Jan 2019
US FDA accepts regulatory submissions for review of tafamidis to treat transthyretin amyloid cardiomyopathy
14 January 2019 - FDA grants a priority review based on Phase 3 ATTR-ACT study findings.
Pfizer announced today that the US FDA accepted for filing the company’s new drug applications for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted two applications 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 under-diagnosed condition.
The tafamidis meglumine form (20 mg capsule) has been granted priority review.
The target Prescription Drug User Fee Act action date for a decision by the FDA is in July 2019.
