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Taxiarchis Kourelis
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Tafamidis Generic Wins EU Backing for ATTR Cardiomyopathy

Source
Medscape

A generic medicine for hereditary transthyretin amyloidosis with cardiomyopathy could soon become more widely available in Europe.

At its July 2026 meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of Tafamidis Accord (tafamidis, Accord Healthcare), a generic version of Vyndaqel, for adults with hereditary transthyretin amyloidosis with cardiomyopathy. 

The positive opinion supports marketing authorization for the 61-mg capsule formulation after demonstration of bioequivalence to the reference medicine, Vyndaqel.