Is Acoramidis approved by the US FDA?

Drugs@FDA lists 1 application product line for Acoramidis, including ATTRUBY (Prescription).

Is Acoramidis authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Acoramidis: Beyonttra.

Active substance

Acoramidis

US FDA 1
EMA 1

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ATTRUBY	EQ 356MG BASE	tablet · oral	BRIDGEBIO PHARMA	Prescription	22 Nov 2024

EMA European Union — centrally authorised medicines

Beyonttra Bayer AG · Authorised · authorised 10 Feb 2025 · ATC C01EB25

Therapeutic indication (EMA)

For the treatment of wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM).

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.