Sanofi Launches Breakthrough Cardiovascular Drug Praluent® (Alirocumab) in China to Address Unmet Needs in Atherosclerotic Cardiovascular Disease
Sanofi
Pharmaceutical R&D Developer
Shanghai, April 21, 2020 /PRNewswire/ --April 19,Sanofi Announces Alirocumab Injection (Brand Name: Praluent)®，Praluent®) Listed in China。As a PCSK9 inhibitor lipid-lowering drug, Bolida®Its market launch in China provides an important new therapeutic option for the vast population of patients with suboptimal outcomes in anti-atherosclerotic therapy, particularly by reducing the risk of major adverse cardiovascular events (MACE) and all-cause mortality.[1]Meanwhile, the “Care for Lida – Plavix Patient Assistance Program” was officially launched to help patients with acute coronary syndrome (ACS) better manage their disease and associated risks.
Treading on“Wind Fire Wheels”In advance2Months after launch, supporting ChinaACSReduce the Risk of Cardiovascular Events in Patients
Plavix®It can be said that it entered China on the “wind-and-fire wheels” of accelerated approval. In December 2019, it was approved by the Chinese National Medical Products Administration (NMPA) for the prevention of cardiovascular events in patients with atherosclerotic cardiovascular disease, as well as for the treatment of lowering low-density lipoprotein cholesterol levels in primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia. Furthermore, China is Praluent®The first country to approve both indications simultaneously, with successful market launch in China two months ahead of schedule.
“The mortality rate of acute coronary syndrome (ACS) has remained high in recent years, imposing a substantial disease burden. Even after receiving evidence-based preventive treatment, patients with ACS still face a significant residual risk, which is partly associated with LDL-C levels; therefore, lowering LDL-C is central to secondary prevention in ACS patients,” stated Academician Ge Junbo from Zhongshan Hospital Affiliated to Fudan University. Bolida®Not only is it supported by evidence-based data demonstrating a significant reduction in cardiovascular events in patients with ACS, but it is also currently the only[2]Associated with a 15% reduction in all-cause mortality[1]Relevant PCSK9 Inhibitors for Patients with Recent ACS Already on Statin Therapy[3], significantly reducing LDL-C levels by 61%[4]. Moreover, long-term follow-up of ACS patients in China is highly unsatisfactory.[5], poor adherence to long-term medication in patients, while Polida administered via subcutaneous injection once every two weeks®, thus providing a novel option for lipid-lowering therapy, with convenient administration that also helps improve patient adherence.
“Bocida is a potent, evidence-based PCSK9 inhibitor. For patients with acute coronary syndrome (ACS), this medication is indeed necessary. In China, only 10% of ACS patients achieve the target LDL-C level of 70 mg/dL upon hospital admission, and even at discharge, only 30% reach this target. Therefore, there remains significant room for improvement. Currently, more than 4,400 hospitals across China are establishing Chest Pain Centers, among which 1,372 have received accreditation. We should leverage the development of Chest Pain Centers to promote the construction of a comprehensive disease prevention and control system,” stated Professor Huo Yong, Director of the Department of Cardiovascular Medicine at Peking University First Hospital.
Dr. Pius S. Hornstein, General Manager of Sanofi’s Global Established Pharmaceuticals Business Unit in China and President of Sanofi China, stated: “Sanofi boasts over 60 years of extensive experience in the management of cardiovascular diseases, and we are delighted that this breakthrough medication—Plavix®“Successfully launched in China through a fully digital approach. As one of the five new drugs scheduled for launch this year, its market entry will usher in a new chapter for Sanofi in China. By 2025, we expect to introduce more than 25 new medicines and vaccines to China, empowering Chinese patients to thrive.”
China’s First Prescription Issued: Bolida®Officially Entered Clinical Application
Professor Chen Jiyan, Director of the Department of Cardiology at Guangdong Provincial People’s Hospital, stated, “PCSK9 inhibitor lipid-lowering drugs have ushered in a new era in cardiovascular treatment. Their emergence has made cholesterol management more ‘youthful,’ reflecting technological advancements. The market launch of these novel agents enables lower cholesterol levels, delivering greater benefits to patients.”
Professor Qian Juying, Vice President of Zhongshan Hospital Affiliated to Fudan University and a cardiologist, introduced that alirocumab injection, as a novel class of potent lipid-lowering drugs,It can reduce LDL-C by 50% to 60%, or even more, from baseline levels. For patients with acute coronary syndrome (ACS) at very high risk—such as those with elevated baseline cholesterol levels, familial hypercholesterolemia, or recurrent atherosclerotic events—who fail to reach their LDL-C treatment goals despite receiving maximally tolerated statin therapy combined with ezetimibe, alirocumab injection offers clinicians a novel therapeutic option. The advent of such innovative drugs has introduced new strategies for lipid-lowering management in ACS patients.
Plavix®The first domestic prescription has been issued, and it has officially entered clinical application.To provide greater care for adult patients diagnosed with primary hypercholesterolemia or mixed dyslipidemia, as well as those with atherosclerotic cardiovascular disease (ASCVD), alleviate their financial burden, prevent recurrent cardiovascular events, and extend patient survival, Sanofi, in partnership with the China Primary Health Care Foundation, launched the “Care for Lida Patient Assistance Program” nationwide in April 2020. The program is now open for applications, providing medication assistance to eligible patients.
Current Status of Cardiovascular Diseases in China
According to statistics, the number of patients with cardiovascular disease in China has reached 290 million, with an average of approximately 3.5 million deaths from cardiovascular disease annually.[6]Studies have found that ACS (acute coronary syndrome) patients who received guideline-recommended medical therapy after PCI had a 1-year MACE risk of 13.7%.[7], necessitating early intervention to mitigate risks. Furthermore, elevated low-density lipoprotein cholesterol (LDL-C) has been identified as a major risk factor for cardiovascular disease. In patients at very high risk who have experienced a cardiovascular event within the past year, inadequate management may lead to recurrence, posing significant threats to health and life. Data indicate that 80% of patients in this very high-risk group fail to achieve adequate LDL-C control with existing therapies.[8], which means that such patients urgently need innovative treatment measures. Among them, the need is more urgent for patients with acute coronary syndrome (including myocardial infarction and unstable angina) who have already been treated with statins but whose LDL-C levels still do not meet the target.
About ODYSSEY OUTCOMESResearch
The ODYSSEY OUTCOMES trial (n = 18,924) evaluated Praluent®Impact on Major Adverse Cardiovascular Events (MACE) in Patients Who Experienced Acute Coronary Syndrome (ACS) Within 1 to 12 Months (Median: 2.6 Months) Prior to Enrollment and Were Receiving High-Intensity or Maximally Tolerated Statin Therapy. Patients Were Randomized to Receive Praluent®(n = 9,462) or placebo (n = 9,462), with a median follow-up of 2.8 years and treatment duration up to 5 years in some patients. Approximately 90% of patients received high-intensity statin therapy.
Praluent®The starting dose is 75 mg (once every two weeks). If LDL-C levels remain above 50 mg/dL at the second month, the dose is increased to 150 mg (once every two weeks). Patients on the 150 mg dose who have two consecutive LDL-C measurements below 25 mg/dL may be switched to 75 mg in a blinded manner. Patients on the 75 mg dose with two consecutive LDL-C measurements below 15 mg/dL (n = 730) are switched to placebo treatment.
The primary endpoint was the first occurrence of major adverse cardiovascular events (MACE), a composite of coronary heart disease (CHD) death, nonfatal myocardial infarction, fatal or nonfatal ischemic stroke, and hospitalization for unstable angina. The key secondary endpoints (hierarchical analysis) included: CHD events (a composite of CHD death, nonfatal myocardial infarction, hospitalization for unstable angina, and ischemic coronary revascularization); major CHD events (a composite of CHD death and nonfatal myocardial infarction); cardiovascular events (a composite of nonfatal myocardial infarction and nonfatal ischemic stroke); a composite of all-cause death, nonfatal myocardial infarction, and nonfatal ischemic stroke; CHD death; cardiovascular death; and all-cause death.
About Polida®(Praluent®)
Praluent®As an innovative PCSK9 inhibitor, it inhibits the binding of PCSK9 (proprotein convertase subtilisin/kexin type 9) to LDL receptors, thereby increasing the number of available LDL receptors on the surface of hepatocytes to clear LDL, lowering LDL-C levels in the blood, and effectively reducing the risk of cardiovascular events in patients with ASCVD.
Praluent®Approved in more than 60 countries worldwide, including the United States, Japan, Canada, Switzerland, Mexico, and Brazil, as well as the European Union (EU). In the United States, Praluent®Approved to reduce the risk of cardiovascular events in adult patients with diagnosed cardiovascular disease, and to lower LDL-C levels in adult patients with primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) as monotherapy or in combination with other lipid-lowering therapies (such as statins and ezetimibe) on the basis of dietary control.
About the China Primary Health Care Foundation
China Primary Health Care Foundation is a national public fundraising foundation hosted by the Chinese Peasants and Workers Democratic Party, supervised by the National Health Commission, and registered and administered by the Ministry of Civil Affairs. It is a public welfare organization with branded charitable programs, standardized internal management, a leading scale of public welfare activities nationwide, and a high reputation and influence within the industry. Since its establishment on December 30, 1996, the Foundation has been committed to its mission of advocating for and mobilizing all sectors of society to care for the development of China’s medical and healthcare services, striving for moral, financial, and material support to build basic healthcare services that are adapted to the level of social development, accessible to all, and affordable to society, thereby safeguarding and improving the health of the people.
Declaration:The information in this article is for reference only and is not intended for promotional purposes. If you have any questions, please consult a doctor or healthcare professional.。
About Sanofi China
Sanofi is a global leader in biopharmaceuticals, dedicated to human health. As one of the first multinational corporations to enter China after the launch of the reform and opening-up policy, Sanofi established its office in China in 1982. Sanofi China’s diversified business portfolio spans pharmaceuticals, human vaccines, and consumer healthcare. In China, Sanofi operates 12 offices, three manufacturing sites, four major R&D centers, and one digital innovation hub. Sanofi is committed to accelerating the introduction of innovative medicines and vaccines into China and leading digital innovation to meet the health needs of the broadest possible population in China.
For more information, please visitwww.sanofi.cn, or follow the “Sanofi China” WeChat official account and the “Sanofi” LinkedIn account.
About Sanofi
Sanofi is dedicated to helping people address health challenges. As a global biopharmaceutical company focused on human health, we prevent diseases through vaccines and provide innovative therapies to alleviate pain and suffering. We support the small number of individuals affected by rare diseases, as well as the millions of patients living with chronic conditions.
Sanofi has more than 100,000 employees across over 100 countries, dedicated to translating scientific innovation into healthcare solutions.Solution.
[1] Only nominal statistical differences were observed under hierarchical analysis; since, in the prespecified hierarchical structure of key secondary endpoints, all-cause mortality followed coronary heart disease mortality and cardiovascular mortality, therefore
The P value for all-cause mortality was considered nominal.
[2] Deadline: April 2020.
[3] Recent ACS patients (1-12 months) treated with the maximum tolerated dose of statins in combination.
[4] At the 12-month follow-up, compared with placebo.
[5] Chinese Circulation Journal, 2019;34(03):209-220.
[6] Report on Cardiovascular Diseases in China 2013.
[7] Catheter Cardiovasc Interv. 2019 Feb 15;93(3):E112-E119.
[8] Halcox JP, et al. Low Rates of Both Lipid-Lowering Therapy Use and Achievement of Low-Density Lipoprotein
Cholesterol Targets in Individuals at High-Risk for Cardiovascular Disease across Europe.PLoS One. 2015;10(2).