EMA Reviews Approval of Bayer's Stroke Drug Asundexian
核心洞察
The European Medicines Agency (搜索) has confirmed Bayer (搜索)'s submission for the factor XIa (搜索) inhibitor asundexian is complete and has started the centralized marketing authorization review.
Bayer (搜索) is pursuing asundexian in secondary prevention of ischemic stroke (搜索), where it showed strong efficacy alongside a low bleeding risk.
The drug failed in 2023 in patients with atrial fibrillation (搜索), and regulators in the United States and China have already granted accelerated review pathways.
The European Medicines Agency (搜索) has accepted Bayer (搜索)'s marketing authorization application for asundexian and confirmed the submission is complete, opening the centralized assessment procedure for the factor XIa (搜索) inhibitor. Bayer disclosed the confirmation in Berlin.
Bayer (搜索) is developing asundexian for secondary prevention of ischemic stroke (搜索), where the drug proved particularly effective with a simultaneously low bleeding risk. The compound had previously failed in 2023 in patients with atrial fibrillation (搜索). Stroke is the second most common cause of death in Europe.
Regulators in the United States and China have already granted Bayer (搜索) an accelerated review pathway for asundexian.
Source: finanznachrichten.de