Sanofi's Clopidogrel and Aspirin Tablet Approved in China for Secondary Prevention of Atherothrombotic Events

By | Pharma Observer

Today, a public notice from China’s National Medical Products Administration (NMPA) indicates that the marketing authorization application for Sanofi’s Class 5.1 new drug, “Clopidogrel and Aspirin Tablets,” has been approved. Public information shows that this antiplatelet single-pill combination (SPC) is indicated for the prevention of atherothrombotic events in adult patients with acute coronary syndrome (ACS) who are already concurrently taking clopidogrel and aspirin.

Screenshot source: NMPA official website

From a mechanistic perspective, aspirin acts as an inhibitor of cyclooxygenase in the arachidonic acid metabolic pathway, suppressing the synthesis of thromboxane A2 (TXA2). This inhibition is irreversible, thereby inhibiting platelet metabolism, altering hemorheological properties, and ultimately exerting an inhibitory effect on thrombus formation. Clopidogrel primarily functions as a platelet P2Y12 receptor antagonist. Its active metabolite effectively binds to adenosine diphosphate (ADP) receptors on the platelet surface, thereby blocking ADP-mediated activation of the glycoprotein complex and ultimately achieving the inhibition of platelet aggregation.

Studies indicate that the combination of aspirin and clopidogrel demonstrates significant therapeutic efficacy in the treatment of acute cerebral infarction. Following administration, it effectively inhibits platelet aggregation, prevents thrombosis, and ultimately achieves effective control of the disease. Furthermore, the combination therapy reduces the incidence of adverse reactions, alleviates patient suffering, shortens treatment duration, minimizes drug-induced systemic damage—particularly to the liver and kidneys—and reduces gastrointestinal irritation.

According to the 《Chinese Expert Consensus on Antiplatelet Therapy with Clopidogrel/Aspirin Single-Pill Combination》, initiated and formulated in 2021 by the Branch of Cardiovascular Physicians, Chinese Medical Doctor Association, results from multiple clinical studies indicate that the antiplatelet efficacy of the clopidogrel/aspirin single-pill combination is non-inferior to that of co-administration of the individual drugs, with comparable tolerability.

According to the consensus, in addition to its efficacy, the specialized formulation of the clopidogrel/aspirin single-pill combination can also reduce adverse reactions. The tablet core contains 100 mg of aspirin; the intermediate enteric-coated layer ensures that aspirin is released in the intestine rather than dissolving in the stomach; and the outer layer is an immediate-release layer containing 75 mg of clopidogrel sulfate, enabling rapid onset of action. Compared with capsules or non-enteric-coated tablets, this dosage form reduces aspirin-induced gastrointestinal adverse reactions. Furthermore, the combination product improves patient medication adherence, thereby improving the prognosis for patients with coronary artery disease on long-term antiplatelet therapy.

According to statistics, the prevalence and mortality rates of cardiovascular disease in China remain on an upward trend. Although the ACS diagnosis and treatment guidelines in Europe, the United States, and China uniformly recommend antiplatelet therapy for all ACS patients, clinical practice still faces challenges such as poor adherence to antiplatelet therapy and a high incidence of bleeding and ischemic events.

According to publicly available information from Sanofi, the development of the clopidogrel/aspirin single-pill combination simplifies the treatment regimen. This not only facilitates patient management but is also expected to improve clinical outcomes. It is hoped that the approval of this new drug from Sanofi will enable more patients to benefit.

References:

[1] Release of Information on Drug Approval Documents Available for Collection on October 11, 2021. Retrieved October 11, 2021, from https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20211011140106162.html

[2] Xu Yawei, Zhang Shuning. Chinese Expert Consensus on Antiplatelet Therapy with Clopidogrel/Aspirin Single-Pill Combination[J]. Chinese Journal of Interventional Cardiology, 2021, 29(06):306-312.

[3] Li Biyan, Song Zulan, Chen Yu. Clinical efficacy of aspirin combined with clopidogrel in the treatment of acute cerebral infarction[J]. Contemporary Medicine, 2021, 27(26): 18-20.

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