New approval in Europe for Nilemdo and Nustendi

The European Commission (EC) has approved the label update of both Nilemdo (bempedoic acid) and Nustendi (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolamia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events, said the European subsidiary of Japan’s Daiichi Sankyo (TYO: 4568) and partner Esperion Therapeutics (Nasdaq: ESPR) in a joint statement.

The EC’s decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C-lowering treatments indicated for primary and secondary prevention of cardiovascular events.

In Europe, around one in seven people have high LDL-C levels, and cardiovascular disease is the leading cause of death, responsible for more than 10,000 lives lost every day. However, up to 80% of patients do not reach guideline-recommended LDL-C goals despite receiving treatments such as statins and are at increased risk of a heart attack or stroke.3,4,5,6