United States-based Pfizer has received priority review from the US Food and Drug Administration (FDA) for its tafamidis meglumine form (20mg capsule) intended for the treatment of transthyretin amyloid cardiomyopathy, it is reported today.

The company filed two new drug applications with the regulator including the two forms of tafamidis, meglumine salt and free acid. It stated that tafamidis free acid form (61mg capsule) will be under standard review, while the prescription drug user fee act action date for a decision on the meglumine salt form of the drug is scheduled to be taken by the US FDA in July this year.

The product is a small molecule that has been developed to selectively bind at particular sites on the transthyretin tetramer to halt destabilisation of the transthyretin transport protein and formation of amyloid that causes transthyretin amyloid cardiomyopathy. According to Pfizer, tafamidis is the only product to complete a phase three clinical trial for efficacy, safety, and tolerability in patients with the condition.