Sanofi's Breakthrough Lipid-Lowering Drug Praluent (Alirocumab) Approved in China for Cardiovascular Event Prevention and Hypercholesterolemia Treatment

Shanghai, January 6, 2020 /PRNewswire/ -- Recently, Sanofi announced that the China National Medical Products Administration (NMPA) has officially approved alirocumab injection (brand name: Praluent®) for the prevention of cardiovascular events in patients with atherosclerotic cardiovascular disease, as well as for the treatment to reduce low-density lipoprotein cholesterol levels in primary hypercholesterolemia (heterozygous familial and non-familial) and mixed dyslipidemia.

As a PCSK9 inhibitor lipid-lowering agent, the approval of alirocumab injection provides an important new treatment option for the vast number of patients in China with suboptimal anti-atherosclerotic therapy, particularly in reducing the risk of major adverse cardiovascular events (MACE) and all-cause mortality.

“Healthy China Action (2010–2030)” focuses on the two core areas of disease prevention and health promotion, proposing the launch of 15 major special initiatives, including the prevention and treatment of cardiovascular and cerebrovascular diseases, to facilitate a shift from a disease-treatment-centered approach to a people’s-health-centered approach. Alirocumab injection was included in the National Priority Review List for Innovative Drugs and granted accelerated approval on March 26, 2019, serving as another testament to China’s emphasis on the prevention and control of cardiovascular diseases.

Compared with existing therapies, alirocumab injection can significantly reduce the risk of cardiovascular events in patients with acute coronary syndrome and is associated with a reduced risk of all-cause mortality. The approval of alirocumab injection in China is primarily based on the Phase III clinical trial named “ODYSSEY OUTCOMES,” which enrolled 18,924 patients. The results demonstrated that alirocumab injection significantly reduced the risk of major adverse cardiovascular events (MACE) by 15% in patients with acute coronary syndrome, and was associated with a 15% reduction in the risk of all-cause mortality.

Professor Huo Yong, Director of the Department of Cardiology at Peking University First Hospital and Principal Investigator for the China region of this trial, stated, “Overall, lipid management strategies in clinical practice in China are relatively conservative, and many patients fail to achieve target lipid levels even after taking lipid-lowering medications. Through nearly a decade of basic and clinical research, PCSK9 inhibitors have emerged as a new generation of LDL-C-lowering agents and an effective class of anti-atherosclerotic drugs. The advent of these drugs represents a revolutionary advancement in the history of anti-atherosclerotic disease treatment, demonstrating potent lipid-lowering efficacy. The innovative product alirocumab injection, now approved for marketing, has clear scientific evidence supporting its effectiveness in lowering cholesterol levels. We believe it will provide new therapeutic options for patients undergoing anti-atherosclerotic treatment in China.”

Dr. Pius S. Hornstein, PhD, General Manager of Sanofi China and Emerging Markets Global Business Unit – China Region, and President of Sanofi China, stated: “Over its 37 years in China, Sanofi has leveraged its long-standing history and extensive experience in cardiovascular therapy to bring alirocumab, a breakthrough medication, to the Chinese market. Its approval will provide new options for public health solutions in China by significantly improving patient outcomes. This also serves as another testament to Sanofi’s positive and profound impact on enhancing the quality of life for the Chinese population through its continuously expanding product portfolio. By 2025, we will introduce more than 25 new medicines and vaccines to China, further contributing to the ‘Healthy China 2030’ strategy.”