The United States Food and Drug Administration (FDA) has approved United States-based Pfizer's Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) intended to treat patients with transthyretin amyloid cardiomyopathy, it was reported yesterday.

The products received approval to treat cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to decrease cardiovascular mortality and cardiovascular-related hospitalisation. Both products are oral transthyretin stabilisers that selectively bind to transthyretin, allowing to stabilise the tetramer of the transthyretin transport protein and slowing the formation of amyloid that causes ATTR-CM.

According to the company, the recommended dosage is either Vyndaqel 80mg orally once-daily, taken as four 20mg capsules, or Vyndamax 61mg orally once-daily, taken as a single capsule. The approval was based on results from the pivotal phase three transthyretin amyloidosis cardiomyopathy clinical trial (ATTR-ACT), in which Vyndaqel significantly decreased the hierarchical combination of all-cause mortality and frequency of cardiovascular-related hospitalisations compared to placebo over a 30-month period, according to the company.