FDA grants Bayer's oral FXIa inhibitor asundexian Fast Track designation!

By specifically targeting proteins involved in pathological thrombosis, but leaving pathways involved in physiological vascular healing intact, FXIa inhibitors can prevent events such as stroke and myocardial infarction (MI) without a corresponding increase in bleeding risk

Bayer today announced that the U.

Fast Track Designation (FTD) is designed to expedite the development and expedited review of drugs for serious diseases that address serious unmet medical needs in key areas

asundexian is an oral factor XIa (FXIa) inhibitor currently being developed as a potential drug for secondary prevention in patients with NCIS, as well as 2 other diseases: atrial fibrillation (irregular heartbeat) and recent myocardial infarction (heart attack)

Currently, Bayer is conducting Phase 2 clinical trials of asundexian in all 3 indications, either as monotherapy or in combination with antiplatelet therapy

By specifically targeting proteins involved in pathological thrombosis, but leaving pathways involved in physiological vascular healing intact, FXIa inhibitors can prevent events such as stroke and myocardial infarction (MI) without a corresponding increase in bleeding risk

The asundexian project aims to provide further support for the hypothesis that inhibition of FXIa with asundexian reduces the risk of thrombotic events without increasing the risk of bleeding