FDA Grants Fast Track Designation for Heart Failure Treatment

Arena Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) granted Fast Track designation for APD418, a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope, in development for the treatment of decompensated heart failure (DHF).

"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 Chris Cabell, MD, MHS, FACC, 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."

APD418 is a first-in-class β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope for decompensated heart failure (DHF). APD418 is a selective antagonist designed to improve cardiac contractility with minimal effect on heart rate, blood pressure and myocardial oxygen consumption, thus potentially avoiding adverse events associated with current inotrope therapies. Arena discovered and developed this investigational drug candidate internally.

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