FDA Grants Fast Track Designation to Bayer's Asundexian for Stroke Prevention in Atrial Fibrillation Patients

Bayer has officially announced that the U.S. FDA has awarded Fast Track Designation to their investigational drug known as asundexian (BAY2433334). This designation recognizes its potential use as a treatment to prevent stroke and systemic embolism in individuals diagnosed with atrial fibrillation (AF). This follows its 2022 Fast Track Designation for preventing stroke in patients after non-cardioembolic ischemic strokes.

Publish Date: 16-05-2023 Source: Bayer

Atrial fibrillation (AF) is the most typical sustained cardiac arrhythmia. AF is often associated with other chronic cardiovascular conditions, including hypertension and heart failure, and long-term AF can result in a significantly raised risk of stroke. AF causes an estimated 15% of all strokes, and it accounts for one-third of strokes in individuals aged 65 years or older. AF is a complex disease with only a partly elucidated pathophysiology; it is the subject of extensive medical research, believing that a complete understanding of AF will yield novel drug therapies with improved effectiveness and safety profiles over current drugs. In keeping with other forms of cardiac arrhythmia, both a triggering factor and a substrate are thought to be required for AF induction; early-stage research has identified several novel targets that have the potential to prevent abnormal impulse formation (the trigger) and help reverse long-term structural and electrical remodeling. Guidelines prepared by the American Heart Association (AHA)/American College of Cardiology (ACC)/European Society of Cardiology (ESC) classify AF into four major categories. Atrial fibrillation (AF) is classified based on its duration and its reversibility into sinus rhythm. The last three categories apply to recurrent AF episodes. The first-detected episode of AF can be symptomatic or self-limiting, and the diagnosing physician may be uncertain about the episode’s duration and previous episodes.

Atrial fibrillation (AF) prevalence increased from 0.1% among adults younger than 55 years to 8.5% in 80 years or older persons. Approximately 2.12 MN to 2.4 MN US adults are currently diagnosed with AF.

However, the current Atrial fibrillation (AF) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (Abelacimab, OMT-28, HBI-3000, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Atrial fibrillation treatment. The key companies in the advanced development stage are Anthos Therapeutics, Inc., Omeicos Therapeutics GmbH, HUYABIO International, LLC., etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Atrial fibrillation (AF) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2021 to 2032.

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