EMA approves Nustendi for primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.- Daiichi Sankyo + Esperion

Esperion announced the European Commission approved the Nustendi (bempedoic acid and ezetimibe) tablet, an oral, once-daily, non-statin LDL-cholesterol (LDL-C) lowering medicine for hypercholesterolemia and dyslipidemia in Europe. Nustendi contains bempedoic acid and ezetimibe and lowers elevated LDL-C through complementary mechanisms of action by inhibiting cholesterol synthesis in the liver and absorption in the intestine.

The European Commission approved Nustendi for use in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet: in combination with a statin in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe, alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone, or in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.

“For the first time, a non-statin once-a-day pill with significant efficacy will be available across Europe to fight bad cholesterol,” said Tim M. Mayleben, president and chief executive officer of Esperion. “This is a major advancement for the millions of patients needing an additional option to use with their statin and know it’s important for them to achieve recommended LDL-C goals or for those that may be statin intolerant.”

The European Society of Cardiology and European Atherosclerosis Society recommend intensively lowering LDL-C to reduce cardiovascular risk. Even today, up to 80% of patients do not reach recommended LDL-C goals despite receiving treatments such as statins, and are at increased risk of a heart attack or stroke. Nustendi provides patients and their physicians an important new oral, once-daily non-statin option.

“There is a compelling need for a once-daily pill with the kind of efficacy Nustendi (bempedoic acid plus ezetimibe combination) can provide for millions of patients, including those that are statin intolerant,” said Professor Kausik K. Ray, MBChB, MD, MPhil, FRCP, Professor of Public Health at the School of Public Health, Imperial College London and a Consultant Cardiologist and member of the Phase III steering committee for Esperion. “This daily medicine will be beneficial for those that need additional lowering of bad cholesterol on top of statins but will also provide a convenient alternative for a significant number of people who cannot tolerate statins. These patients now have an efficacious oral option to lower their bad cholesterol. A single combination pill aides adherence, a critical factor to maintain long-term reductions in bad cholesterol.”

The approval of NustendiI is supported by the Phase III Fixed Combination Tablet LDL-C Lowering program, as well as safety data from the Nilendo (bempedoic acid) tablet global pivotal Phase III LDL-C lowering program and the existing ezetimibe safety profile. Nustendi lowered LDL-C by a mean of 38 percent compared to placebo when added on to maximally tolerated statins. Results have been published in The European Journal of Preventive Cardiology. The benefit with Nustendi is its ability to reduce levels of LDL-C in patients with hypercholesterolaemia or mixed dyslipidaemia when administered alone and in combination with other lipid-modifying medicinal products. Nustendi also reduced non-high-density lipoprotein cholesterol (n, apon-HDL-C)olipoprotein B (apo B) and total cholesterol (TC). Notably, the pharmacology section of the Nustendi label highlights that among the subset of patients with diabetes (n=1,134), lower levels of hemoglobin A1c (HbA1c) were observed as compared to placebo (on average 0.2%).

Nustendi was generally well-tolerated in clinical studies. The most commonly reported adverse reactions with Nustendi were hyperuricaemia and constipation. The majority of adverse reactions reported with Nustendi were mild to moderate in severity and balanced in occurrence with adverse events in patients receiving placebo. In pooled placebo-controlled clinical trials with bempedoic acid, a component of Nustendi, more patients on bempedoic acid compared to placebo discontinued treatment due to muscle spasms, diarrhea, pain in extremity and nausea, although differences between bempedoic acid and placebo were not significant.

Daiichi Sankyo Europe has licensed exclusive commercialization rights to Nilendo and Nustendi in the European Economic Area and Switzerland from Esperion.