Bayer's Rivaroxaban Tablets Nominated for Priority Review in China for Domestic Production Transfer

Sep 02, 2024 14:57 CST Updated 14:57

Bayer

Pharmaceutical Product R&D Developer

▎WuXi AppTec Content Team Report

Today (September 2), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China,Bayer（Bayer）Rivaroxaban Tablets Meet NMPA "Requirements for...Marketing Authorization Application for the Transfer of Original Chemical Drugs and Biologics to Production within China"The situation is proposed to be included in the priority review."

Public information shows that the NMPA released a public consultation on the "Announcement on Optimizing the Relevant Matters of the Marketing Authorization Application for the Transfer of Drugs Already Listed in China from Overseas Production to Domestic Production" in the first half of 2024.It was mentioned that,Marketing Authorization Application for the Transfer of Original Chemical and Biological Products to Production within China, included in the priority review and approval scope by the National Medical Products Administration (NMPA).

Screenshot source: CDE official website

Public information shows that Rivaroxaban Tablets are aNon-vitamin K antagonist oral anticoagulantsIt can inhibit factor Xa, interrupt the intrinsic and extrinsic pathways of the coagulation cascade, and suppress thrombin generation and thrombosis. Globally, rivaroxaban has been approved for marketing in more than 130 countries or regions.Provide protection for patients with various venous and arterial thromboembolismsNotably, the product was also selected for Fierce Pharma's list of the top 20 globally in 2021.Blockbuster DrugList.

In China, the product has also been approved for various indications, includingFor the prevention of venous thromboembolism in adult patients undergoing elective hip or knee replacement surgery, adult patients with non-valvular atrial fibrillation, patients with coronary artery disease or peripheral artery disease, and for the prevention and treatment of VTE, etc.。

This Rivaroxaban TabletThe indications targeted for priority review include:

2.5mg: Rivaroxaban combined with Aspirin (ASA) forAdult patients with coronary artery disease (CAD) at high risk of ischemic events, to reduce the risk of major cardiovascular events (cardiovascular death, myocardial infarction, and stroke). Rivaroxaban is administered in combination with aspirin forAdult patients with peripheral artery disease (PAD)(including patients who have recently undergone lower extremity revascularization due to symptomatic peripheral artery disease (PAD)) to reduce the risk of major thrombotic events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation due to vascular disease).
10mg, 15mg and 20mg: For adult useAdult patients undergoing elective hip or knee replacement surgery to prevent venous thromboembolism (VTE)；Used forTreatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults；In patients with persistent risk of DVT and/or PE recurrence after completing at least 6 months of initial treatment, used forReduce the risk of DVT and/or PE recurrence。Used for having one or more risk factors (e.g.:Congestive heart failure, hypertension, age ≥75 years, diabetes, history of stroke or transient ischemic attack)Adult patients with non-valvular atrial fibrillation to reduce the risk of stroke and systemic embolism。Pediatric population for those under 18 years old and weighing between 30 kg-50 kg and above 50 kg.Treatment of Venous Thromboembolism (VTE) and Prevention of VTE Recurrence in Children and Adolescents After at Least 5 Days of Initial Non-Oral Anticoagulation Therapy。

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 30, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2]https://www.who.int/zh/news-room/fact-sheets/detail/rabies

[3]https://www.mayoclinic.org/zh-hans/diseases-conditions/rabies/symptoms-causes/syc-20351821

This article was compiled and edited by the WuXi AppTec content team based on publicly available information. Feel free to share it on your personal social media. For authorization to repost or other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.

Disclaimer: The content team of WuXi AppTec focuses on introducing the research progress in global biopharmaceuticals and health. This article is for information exchange only, and the views expressed in the article do not represent the position of WuXi AppTec, nor does it indicate that WuXi AppTec supports or opposes these views. This article is not a recommendation for treatment plans. For guidance on treatment options, please visit a正规 hospital.