Admin_Adham
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.
New Option for ATTR Cardiomyopathy
The recommended indication covers the treatment of adult patients with hereditary transthyretin amyloidosis and cardiomyopathy. Tafamidis, the active substance in Tafamidis Accord, is a selective stabilizer of transthyretin tetramer, targeting the underlying protein misfolding responsible for disease progression.
The generic product contains the same active substance and strength (61 mg) as the reference medicine.
Bioequivalence Supports Approval
The CHMP's recommendation is based on evidence that Tafamidis Accord is bioequivalent to Vyndaqel, which has been authorized in the European Union since November 2011. The generic approval pathway therefore relied on established efficacy and safety data for the reference product, together with bioequivalence and quality studies.
Specialist Prescribing and Next Steps
Treatment should be initiated under the supervision of a physician knowledgeable in the management of patients with amyloidosis or cardiomyopathy.
The CHMP opinion now moves to the European Commission, which typically issues a legally binding marketing authorization decision within approximately 67 days. Following approval, the full Summary of Product Characteristics will be published on the EMA website in all official European Union languages.
