Bempedoic acid/ezetimibe combo hits goals in Ph III study

31 July 2019

Japanese drugmaker Daiichi Sankyo (TYO: 4568) saw its shares rise 6.45% to 6,647 yen today after it revealed that positive results from the 12-week, pivotal Phase III bempedoic acid/ezetimibe FDC tablet study (Study 053) were published in the European Journal of Preventative Cardiology.

Bempedoic acid and its FDC tablet are currently undergoing regulatory review for marketing authorization by the European Medicines Agency and by the US Food and Drug Administration. The product is licensed to Daiichi Sankyo for Europe by USA-based Esperion Therapeutics (Nasdaq: ESPR).

Study 053 evaluated the efficacy, safety, and tolerability of the bempedoic acid/ezetimibe FDC tablet in patients with hypercholesterolemia and a history of atherosclerotic cardiovascular disease or at high risk for atherosclerotic cardiovascular disease receiving maximally tolerated statin therapy (including potentially no statin).

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