Tafamidis (Vyndaqel; Vyndamax): Why Two Products?

Our website now hosts a free article about tafamidis, a new drug in the US approved for treatment of adults with transthyretin-mediated amyloid cardiomyopathy, a progressive, life-threatening, under-diagnosed disease often referred to by its acronym (ATTR-CM). The drug was approved in 2 formulations with different brand names and different doses, both manufactured by Pfizer.

Vyndaqel (tafamidis meglumine) has been approved in Europe since 2011 for treatment of transthyretin amyloid polyneuropathy (ATTR-PN) and is now approved for that indication in 40 countries. It is formulated as 20-mg capsules; the dose recommended for treatment of ATTR-CM is 80 mg once daily.

Vyndamax (tafamidis) is brand new. It is formulated as 61-mg capsules; the recommended dose is 61 mg once daily. The package insert, which the two drugs share, states that no clinically significant pharmacokinetic differences in peak blood levels (Cmax) or concentration/time curve (AUC) were observed between 4 capsules of Vyndaqel and a single capsule of Vyndamax.

The pivotal clinical trial randomized patients to 20- or 80-mg doses of Vyndaqel or placebo. Patients taking either dose of the active drug were pooled and compared to the patients on placebo; all-cause mortality and cardiovascular hospitalizations were significantly less frequent with the drug. Efficacy was the same with either the 20- or the 80-mg dose (MS Maurer et al. Tafamidis treatment for patients with transthyretin cardiomyopathy. N Engl J Med 2018; 379:1007).

According to a company statement, Vyndamax was developed to give patients the convenience of taking one rather than four capsules once a day. Both Vyndaqel and Vyndamax have a wholesale acquisition cost of $18,750 a month. Since 20 mg of Vyndaqel has been as effective as 80 mg, the cost could be cut by 75% by taking the lower dose, as long as Vyndaqel is not phased out to protect the higher price.

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