Fast Track Designation granted to decompensated heart failure treatment

The US Food and Drug Administration (FDA) has granted Fast Track designation to APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope, in development for the treatment of decompensated heart failure (DHF).

The investigational drug candidate was discovered and developed by Arena Pharmaceuticals, Inc.

Decompensated heart failure (DHF) is characterised by an increase in symptoms such as difficulty breathing (dyspnea), exertional intolerance, leg or feet swelling and fatigue. It is the leading cause of hospitalisation for those over 65 years of age, the company said and there have been few new medical therapies approved for DHF over the last 20 years. 

"With approximately 10 million DHF patient hospital visits expected in the US by 2025 and few viable treatment options, we believe that APD418 has the potential to make a significant impact for these patients," said Dr Chris Cabell, Arena’s Senior Vice President and Chief Medical Officer.  "We are pleased with the Fast Track designation and look forward to advancing this program as part of our cardiovascular focus."

Arena Pharmaceuticals has described APD418 as a first-in-class β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope. It is a selective antagonist designed to improve cardiac contractility with minimal effect on heart rate, blood pressure and myocardial oxygen consumption, the company said and thus potentially avoids adverse events associated with current inotrope therapies.

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