Bayer’s (ETR: BAYN) acoramidis has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM), the German pharmaceutical company announced last week.
ATTR-CM and the Impact of Acoramidis
ATTR-CM is a rare disease characterized by the deposition of misfolded transthyretin (TTR) protein in the heart valves, leading to a lack of early diagnostic methods and effective treatments. Acoramidis, an oral TTR stabilizer, has demonstrated its capability for near-complete TTR stabilization. It was approved for marketing in the US last month. The CHMP’s positive opinion is based on the Phase III ATTRibute-CM study, which showed acoramidis’ significant superiority over placebo in reducing the composite of all-cause mortality (ACM) and cardiovascular-related hospitalizations (CVH).
Collaboration Between BridgeBio Pharma and Bayer
Acoramidis originated with US firm BridgeBio Pharma, Inc. (NASDAQ: BBIO) and has been the subject of a collaboration between BridgeBio and Bayer since March 2024. The two companies hold distribution rights to the drug in the US and Europe, respectively. According to the announcement, acoramidis is scheduled for market launch in Europe in the first half of 2025.-Fineline Info & Tech
