Organon Announces China Approval of Innovative Lipid-Lowering Fixed-Dose Combination Therapy YiliTuo® (Ezetimibe and Atorvastatin Calcium Tablets)

Sep 21, 2023 13:28 CST Updated 07:55

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Recently, Organon China announced in the cardiovascular fieldInnovative Compound Preparation Yilituo^®[Common Name:Ezetimibe Atorvastatin Calcium Tablets (Ⅰ) ^[1] / (Ⅱ) ^[2]] Granted marketing authorization approval by the China National Medical Products Administration (NMPA), for use inTreatment of HypercholesterolemiaAndHomozygous Familial Hypercholesterolemia (HoFH)。

Ezetimibe Atorvastatin Calcium Tablets are a fixed-dose combination of ezetimibe and atorvastatin. In clinical practice, both components have been widely used to reduce low-density lipoprotein.Protein cholesterol (LDL-C) levels. Among them,Atorvastatin inhibits the rate-limiting enzyme in the cholesterol synthesis pathway.——Hydroxymethylglutaryl-CoA reductase, thereby reducing hepatic cholesterol synthesis^[3]Ezetimibe reduces intestinal cholesterol absorption and decreases hepatic cholesterol stores by selectively inhibiting the cholesterol transporter protein in the small intestine.^[3]。

Hypercholesterolemia as an Important Risk Factor for Atherosclerotic Cardiovascular Disease (ASCVD)^[4], is one of the common manifestations of dyslipidemia.1. Hypercholesterolemia is characterized by elevated levels of LDL-C or total cholesterol (TC).Effectively lowering LDL-C levels is particularly crucial for managing blood lipid health, especially for patients at higher risk, who should be more proactive in management.Strict control of LDL-C levels can significantly reduce the incidence and mortality risk of ASCVD.^[3]。

However, the DYSIS-China study^[5]Display, in alreadyAmong Chinese patients with dyslipidemia who have been receiving conventional lipid-lowering therapy for three months (the majority being treated with statins alone),The LDL-C target achievement rate for secondary prevention is only 33.09%, with an even lower rate of 26.86% among extremely high-risk patients.Most patients need to adjust their existing lipid-lowering treatment methods to achieve the lipid-lowering goals.The combination of drugs is gradually becoming a basic trend and important strategy in China's lipid-lowering treatment.

Innovative Compound Formulation YiliProper^®The approval will bring a new treatment option for solving the lipid-lowering problem.Professor Ge Junbo, Academician of the Chinese Academy of Sciences and Director of the Cardiology Department at Zhongshan Hospital Affiliated with Fudan University, pointed out:

Atherosclerotic cardiovascular disease is the primary health threat to residents in China, and dyslipidemia is one of the most important risk factors for atherosclerosis.For patients who require combination therapy, especially those at higher risk, both the enhancement of lipid-lowering intensity and the development of treatment adherence are indispensable.The approval and market launch of more innovative lipid-lowering drugs such as Ezetimibe Atorvastatin Calcium Tablets provide clinicians with additional innovative treatment options, benefiting more Chinese patients by helping them achieve their lipid targets. This contributes to the goal of improving patients' quality of life and extending the average healthy life expectancy.

"This time, Yili"Proper^®Approved, Will Better Help Clinicians Tackle Lipid Management Challenges^[5]", meeting the clinical treatment needs of different patients."Wei Fang, Vice President of Organon China and Head of Medical AffairsExpressed, "YiliProper^®"The combination of atorvastatin and ezetimibe synergizes the advantages of two classic lipid-lowering approaches, achieving complementary mechanisms to improve lipid management for patients in China."

"Very pleased to introduce the innovative lipid-lowering compound preparation YiliProper^®Successfully approved in China, it will become an important milestone for us to broaden innovative solutions in cardiovascular disease treatment, helping more Chinese doctors address the differentiated treatment needs in clinical lipid management."Zafer Unluer (Wu Zefa), Global Senior Vice President of Organon and President of China RegionStated: "In the future, we will join hands with partners from all sectors to not only continue bringing more cutting-edge innovative drugs to Chinese patients but also constantly improve the accessibility of medicines, fully safeguarding a healthier and better life for patients every day."

▌AboutYiliProper^®

In 2013, YiliProper^®(Common name: Ezetimibe Atorvastatin Calcium Tablets) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of elevated LDL-C in patients with primary or mixed hyperlipidemia, as well as for reducing cholesterol levels in patients with homozygous familial hypercholesterolemia (FH). In 2016, it was approved in the European Union for reducing cardiovascular event risks in patients with coronary heart disease (CHD) and acute coronary syndrome (ACS), regardless of prior statin treatment. In 2023, China's National Medical Products Administration (NMPA) approved its use for treating hypercholesterolemia and homozygous familial hypercholesterolemia (HoFH).

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▌About Organon

Organon (NYSE: OGN) is a global healthcare company spun off from Merck & Co., focusing on safeguarding women's health throughout their entire life cycle, bringing healthier and better days to women and their families. Organon exists because of her, offering a portfolio of more than 60 drugs and medical solutions worldwide, covering a range of therapeutic areas. With robust cash flow advantages driven by its reproductive health business, continuously growing biosimilars segment, and stable classic brands, Organon is able to consistently invest in future growth and business development opportunities within the field of women’s health. Additionally, Organon is actively seeking collaborations with innovative biopharmaceutical companies, leveraging its scale and resource strengths in rapidly growing international markets to help these companies achieve product commercialization.

Organon has achieved large-scale, extensive development globally and possesses world-class commercial operational capabilities. Headquartered in Jersey City, New Jersey, USA, the company has over 10,000 employees worldwide.

▌AboutOrganon China

Organon is a global leading healthcare company dedicated to safeguarding women's health throughout their entire life cycle.

China is a crucial part of Organon's global strategic blueprint, with Organon's China headquarters located in Shanghai. Committed to its unwavering promise to patients, the company actively aligns with China’s maternal and child health development policies. Through over 20 drugs and medical solutions covering seven major therapeutic areas—fertility, contraception, respiratory, cardiovascular, dermatology, pain management, and bone health—Organon comprehensively safeguards the health of Chinese women and families.

"Creating a healthier and better every day for every woman" is Organon's unwavering vision. In China, the company focuses on two core businesses: women's health and classic brands, and is committed to becoming a pioneer in practicing innovative pharmaceutical retail models in China. With passion, the company sincerely collaborates with partners from all sectors to explore diversified solutions to meet the significant unmet needs of women's health in China, helping Chinese women and the hundreds of millions of families behind them achieve a healthier and better every day.

For more information, please visit Organon China's official website Organonchina.com.cn or follow the official WeChat account "Organon" (OrganonChina).

Remarks:

[1] Ezetimibe and Atorvastatin Calcium Tablets (Ⅰ): Each tablet contains 10mg of ezetimibe and 10mg of atorvastatin calcium (as atorvastatin).

[2]Ezetimibe and Atorvastatin Calcium Tablets (Ⅱ): Each tablet contains 10mg of ezetimibe and 20mg of atorvastatin calcium (as atorvastatin).

[3] International Dyslipidemia Survey-China (DYSIS-China) Study Design: This was a multi-center, cross-sectional, non-interventional epidemiological survey on dyslipidemia conducted from March to October 2012. It enrolled 25,317 outpatients with dyslipidemia who had been receiving drug treatment for at least three months. The study analyzed blood lipid levels and target achievement status according to the criteria of the 2007 Chinese Guidelines on the Prevention and Treatment of Dyslipidemia in Adults.

References:

[1Instructions for Ezetimibe and Atorvastatin Calcium Tablets (Ⅰ)

[2] Instructions for Ezetimibe and Atorvastatin Calcium Tablets (Ⅱ)

[3] Joint Expert Committee for the Revision of China's Lipid Management Guidelines, China Lipid Management Guidelines (2023) [J]. Chinese Circulation Journal, 2023, 38(3):237-271

[4]Ference BA, Ginsberg HN, Graham I, et al. Low‐density lipoproteins cause atherosclerotic cardiovascular disease. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel[J]. Eur Heart J, 2017, 38(32): 2459‐2472. DOI: 10.1093/ eurheartj/ehx144

[5Li Yong, Zhao Shuiping, Ye Ping, et al. Current Status of Lipid-Lowering Treatment for Primary and Secondary Prevention in Chinese Outpatients with Dyslipidemia: A Subgroup Analysis of DYSIS-China. Chinese Journal of Cardiovascular Diseases, 2016, 44(8): 665-670

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