Bayer's FXIa Inhibitor BAY 2433334 Receives Two Clinical Trial Approvals in China for Secondary Stroke Prevention

Source: Medical Perspective

The latest public notice on the website of China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) indicates that Bayer’s Class 1 new drug, BAY 2433334 tablets, has received two implied clinical trial approvals in China. The drug is intended for secondary stroke prevention in patients following acute non-cardioembolic ischemic stroke. BAY 2433334 is an investigational Factor XIa (FXIa) inhibitor currently in Phase II clinical trials globally and has not yet been approved for marketing in any country or region.

Image source: CDE screenshot

Thrombotic diseases include cardiovascular conditions such as coronary artery disease, stroke, and peripheral artery disease. The use of anticoagulants can prevent thrombus-related diseases. Recent studies have shown that factor XIa (FXIa) inhibitors can reduce the incidence of venous thrombosis without significantly increasing bleeding risk. Therefore, FXIa inhibitors are considered to hold significant potential value in the treatment of thrombotic diseases and are regarded as a novel class of antithrombotic agents.

BAY 2433334 is an investigational Factor XIa (FXIa) inhibitor developed by Bayer and has not yet been approved for marketing in any country or region worldwide. According to ClinicalTrials.gov, Bayer is conducting three Phase 2 clinical studies of BAY 2433334 globally, covering indications including acute myocardial infarction, acute non-cardioembolic ischemic stroke, and atrial fibrillation (AF).

In China, BAY 2433334 had previously been approved for a clinical study targeting the following indications: “prevention of thrombosis; prevention of stroke and systemic embolism in patients with atrial fibrillation (prevention of cardioembolic stroke); prevention of stroke in patients after ischemic stroke (large artery atherosclerosis, lacunar stroke, or embolic stroke of undetermined source [ESUS]) (prevention of non-cardioembolic stroke); and prevention of stroke, myocardial infarction (MI), and cardiovascular death in patients after acute coronary syndrome.”

The two clinical trials approved this time target a new indication for secondary stroke prevention in patients after acute non-cardioembolic ischemic stroke (large artery, lacunar stroke, or embolic stroke of undetermined source [ESUS]). Currently, Bayer has registered a randomized, double-blind, international multicenter (including China) Phase 2 clinical trial to evaluate the efficacy and safety of BAY 2433334 in patients with acute non-cardioembolic ischemic stroke.

Ischemic stroke is a general term for brain tissue necrosis caused by stenosis or occlusion of the cerebral blood-supplying arteries (carotid and vertebral arteries) leading to insufficient cerebral blood supply. Non-cardioembolic stroke refers to ischemic stroke and transient ischemic attack (TIA) caused by atherosclerosis, small artery occlusion, other rare causes, or unknown etiologies. Currently, there remains an unmet clinical need among patients with acute non-cardioembolic ischemic stroke.

Congratulations on the approval of Bayer’s FXIa inhibitor BAY 2433334 tablets for new clinical studies in China. We hope the research proceeds smoothly and benefits patients at an early date.

References

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved May 27, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=25

[2] ClinicalTrials.gov website. From https://clinicaltrials.gov/ct2/home

(Original Title: Bayer’s Class 1 Novel FXIa Inhibitor Approved for Clinical Trials in China, Intended for Stroke Prevention)

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