The European Commission approved Pfizer’s Vyndaqel (tafamidis meglumine) 61mg oral capsule to treat wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).
The commission’s approval was based on results of a phase 3 clinical trial that compared patients who received a 20mg or 80mg oral dose of the drug to those given a placebo.
Vyndaqel demonstrated a significant reduction in all-cause mortality and frequency of cardiovascular-related hospitalizations compared to placebo over a 30-month period.
The approval is the EU’s first for patients with the disease. The EU originally approved the drug in 2011 to treat transthyretin amyloid polyneuropathy in adult patients with stage 1 symptomatic polyneuropathy to delay peripheral neurologic impairment.