Novartis receives EU approval for inclisiran, which brings a new approach to treating elevated cholesterol

  • Inclisiran is the  first and only approved small-interfering RNA (siRNA) low-density lipoprotein  cholesterol (LDL-C) lowering treatment in Europe
  • Cardiovascular  disease remains the leading cause of mortality in Europe4, which demonstrates  the urgent need for innovative treatments for patients struggling to reach their LDL-C goals
15. 2. 2021

European Commission (EC) has approved Novartis’ innovative medicine inclisiran for the treatment of adults with hypercholesterolemia or mixed dyslipidemia for patients with elevated LDL-C cholesterol, despite treatment with other lipid-lowering medication.

Inclisiran is the first and only approved medication in Europe that lowers LDL cholesterol (i.e. bad cholesterol) by using one of the natural processes that take place in the body (small-interfering RNA, siRNA). For patients with atherosclerosis, the method of dosing is also an encouraging news, as after two initial doses three months apart, the medicine is administered only twice a year.

Cardiovascular disease is likely to affect the lives of each of us in some way at some point. They are an increasingly common cause of serious complications and are still the leading cause of premature death in our country. In addition, their incidence is increasing as the ever-increasing rates of obesity and the incidence of diabetes contribute to the deterioration of cardiovascular health in the aging population.

What is atherosclerosis?

Cardiovascular diseases are the cause of 3.9 million deaths a year in Europe. The main cause of heart attack, stroke and consequent death is a type of cardiovascular disease called atherosclerotic cardiovascular disease or atherosclerosis. The key factor of atherosclerosis is elevated LDL cholesterol or so called "bad" cholesterol. Unfortunately, effective and long-term reduction of LDL remains a challenge – as many as 80% of patients do not reach the target LDL cholesterol levels with the current standard of care (statins). Inclisiran is therefore an important step forward in this area, as it changes the way LDL cholesterol is treated.

Approval  of inclisiran is an important milestone for Novartis

Bending the curve of life requires addressing some of society’s biggest public health concerns, including cardiovascular disease. Novartis has an established and expanding presence in diseases covering the heart, kidney and metabolic system. In addition to essential treatment for heart failure (sacubitril/valsartan), Novartis has a growing pipeline of potentially first-in-class molecules addressing cardiovascular, metabolic and renal diseases.

The EC marketing authorization for inclisiran is valid in the 27 countries that are members of the EU.

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About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at

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For additional information contact:
Mateja  Breznik
Communication & Engagement
Phone: +386 41 370 634