EC grants marketing authorisation to BridgeBio's ATTR-CM treatment
An orally administered near-complete (≥90%) transthyretin (TTR) stabiliser, acoramidis is designed to combat this progressive fatal disease, which can lead to heart failure.
The approval in the European Union (EU) is based on outcomes from the Phase III ATTRibute-CM trial of the therapy, which demonstrated cardiovascular benefits.
The study involved 632 subjects with symptomatic ATTR-CM and met its primary clinical endpoints at month 30.
It showed a significant decrease in cardiovascular-related hospitalisation, improved survival rates, preserved functional capacity and better quality of life for individuals.
BridgeBio Cardiorenal chief medical officer Dr Jonathan Fox stated: 'The EU approval of acoramidis is a significant advancement for patients living with ATTR-CM in need of new disease-modifying treatments for their condition.
'This approval would not have been possible without the commitment of the clinical trial participants and their families, and the dedicated support of the physicians and scientists involved in the clinical programme.'
Bayer, responsible for all commercial activities for the therapy in the EU, is set to launch Beyonttra in the first half of 2025.
BridgeBio and Bayer initiated a partnership for the therapy in March 2024, granting the latter exclusive commercialisation rights in the EU.
Acoramidis is also under review for approval by the Brazilian Health Regulatory Agency and the Japanese Pharmaceuticals and Medical Devices Agency.
The latest development follows the therapy's approval under the name of Attruby by the US Food and Drug Administration in November 2024 to treat adults with ATTR-CM.
"EC grants marketing authorisation to BridgeBio's ATTR-CM treatment" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand.
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