Chinese Patients with Atherosclerotic Cardiovascular Disease Set to Gain Timely Access to Innovative PCSK9 Inhibitor Alirocumab

On March 26, 2019, the Center for Drug Evaluation (CDE) of the National Medical Products Administration officially included Sanofi’s PCSK9 inhibitor lipid-lowering drug, alirocumab injection (provisional name: Alirocumab; English brand name: Praluent), in the priority review program, thereby accelerating its review and approval process.

Praluent’s priority review in China covers two indications (subject to final approval): first, for adult patients with primary hypercholesterolemia (heterozygous familial and non-familial) or mixed dyslipidemia; second, for reducing the risk of cardiovascular events in patients with atherosclerotic cardiovascular disease.

Once officially approved, it will enable Chinese patients to access this innovative drug in sync with the global community.

Priority Review “Green Channel” Accelerates the Entry of Innovative Drugs into China

Since the reform of the drug review and approval system, China’s drug regulatory policies have accelerated their alignment with international standards. A series of coordinated measures have been implemented, continuously expediting the review and approval of innovative drugs and those urgently needed for clinical use. A number of such clinically urgent medications have been successively approved, providing effective support for meeting clinical medication needs and promoting public health. Song Ruilin, Executive President of the China Pharmaceutical Innovation Promotion Association, stated, “Chinese patients can now access high-quality global innovative drugs more rapidly. The inclusion of Praluent, a PCSK9 inhibitor lipid-lowering drug, in the priority review program is one example. In the past, the market launch of innovative drugs in China lagged behind Europe and the United States by 5 to 7 years. Today, reforms in drug review have enabled Chinese patients to tangibly benefit from these policy dividends.”

Praluent’s eligibility for the Priority Review “Green Channel” was primarily based on the Phase III clinical trial named “ODYSSEY OUTCOMES.” The results demonstrated that Praluent significantly reduces the risk of cardiovascular events in patients with acute coronary syndrome and is associated with a reduced risk of all-cause mortality: the risk of major adverse cardiovascular events (MACE) was reduced by 15%, and the risk of all-cause mortality was also reduced by 15%. Professor Huo Yong, Director of the Department of Cardiology at Peking University First Hospital and the principal investigator for the China region of this trial, stated, “Through nearly a decade of basic and clinical research, PCSK9 inhibitors have become a new generation of LDL-C-lowering agents and an effective class of anti-atherosclerotic drugs. The emergence of these drugs represents a revolutionary advance in the history of anti-atherosclerotic disease treatment.” This long-term trial enrolled 18,924 patients, including 614 from China.

Favorable Policies Encourage Corporate Innovation and Development, Bringing Benefits to Patient Health

Conducting clinical trials in sync with global efforts, achieving positive research outcomes, and having two indications simultaneously included in the priority review process all contribute to significantly shortening the time for Praluent’s approval and market launch in China. Mr. Jin Xiaodong, Vice President of Sanofi China and General Manager of the Core Products Division, stated, “Priority review is a key reform initiative implemented by the government in recent years. Sanofi will actively support these reforms, respond to policy calls, and continue to accelerate the introduction of high-quality innovative original drugs into China, thereby contributing to improved accessibility and affordability of medications for Chinese patients and bringing benefits to the public at an earlier date.”

According to statistics, the number of patients with cardiovascular disease (CVD) in China has reached 290 million, with approximately 3.5 million deaths from CVD annually. Elevated low-density lipoprotein cholesterol (LDL-C) is recognized as a major risk factor for cardiovascular events. In particular, among very high-risk patients who have experienced a cardiovascular event within the past year, inadequate intervention may lead to recurrence, posing serious threats to health and life. Data indicate that 80% of very high-risk patients fail to achieve adequate LDL-C control with existing therapies, highlighting an urgent need for innovative treatment approaches. This need is even more pressing for patients with acute coronary syndrome (ACS), including myocardial infarction and unstable angina, whose LDL-C levels remain uncontrolled despite statin therapy.

Regarding Priority Review

In December 2017, the China Food and Drug Administration issued the "Opinions on Encouraging Drug Innovation and Implementing Priority Review and Approval," to accelerate the research, development, and market launch of new drugs with clinical value and generic drugs urgently needed for clinical use. Drug registration applications that meet the specified criteria will be included in the scope of priority review and approval.

The “Opinions” provide detailed provisions on the priority review and approval process, and since their implementation, the market launch speed of many innovative drugs has been significantly accelerated.