CHMP issues positive opinions for both bempedoic acid and the bempedoic acid / ezetimibe fixed-dose combination tablet as treatments for hypercholesterolaemia and significantly reducing ca...
DAIICHI SANKYO S/ADR (DSNKY)
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Source: Yahoo! Finance
European Commission decision on label update authorisation applications are expected to be made in the mid of the year 2024. MUNICH, Germany, March 22, 2024 BUSINESS WIRE )--Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo') and Esperion Therapeutics, Inc. jointly announced today, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted positive opinions for the label update of both bempedoic acid ( marketed as NILEMDO ® ? and the bempedoic acid / ezetimibe fixed dose combination (FDC) ( marketed as NUSTENDI ® ? , recommending their approval as treatments to reduce low-density lipoprotein cholesterol (LDL-C) and cardiovascular risk. The existing label of bempedoic acid ( NILEMDO ® ? provides authorisation for adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin or statin with other lipid-lowering therapies in pa
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