Germany-headquartered Bayer (ETR: BAYN) has received marketing approval from the European Medicines Agency (EMA) for its drug acoramidis, commercially known as Beyonttra. This near-complete (≥90%) transthyretin (TTR) stabilizer can now be used to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM) in the European Union (EU).
About ATTR-CM and the Drug’s Approval Basis
ATTR-CM is a progressive fatal disease characterized by infiltrative, restrictive cardiomyopathy that leads to heart failure. It currently lacks effective early diagnostic methods and treatment measures. The EMA’s regulatory decision is based on the positive results from the Phase III ATTRibute-CM study. The study showed that acoramidis was significantly superior to placebo in the composite endpoints of reducing all-cause mortality (ACM) and cardiovascular-related hospitalization (CVH).
Collaboration and Market Launch Plans
Acoramidis, which received FDA approval in November last year, has been the focus of a collaboration between Bayer and BridgeBio Pharma, Inc. (NASDAQ: BBIO) since March 2024. Bayer holds the drug’s distribution rights in Europe, while BridgeBio Pharma holds the rights in the US. The drug is scheduled for market launch in the US during the first half of this year.-Fineline Info & Tech
