Arena Pharmaceuticals gains ‘Fast Track Designation’ by FDA for APD418

U.S. Food and Drug Administration (FDA) recently granted the ‘Fast Track Designation’ to Arena Pharmaceuticals for APD418 – “a β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope, in development for the treatment of decompensated heart failure (DHF)”.

DHF is a sudden worsening of the symptoms of heart failure, that typically include difficulty in breathing or dyspnea, swelling of the legs or feet, and fatigue. It is a common and potentially serious cause of acute respiratory distress, caused by severe congestion of multiple organs by fluid that is inadequately circulated by the failing heart.

An attack of decompensation can be caused by an underlying medical illness, such as myocardial infarction – an abnormal heart rhythm, infection or a thyroid disease. General symptoms include external dyspnea – difficulty breathing during exercise, orthopnea – difficulty breathing while lying flat, paroxysmal nocturnal dyspnea – episodes of waking up from sleep gasping for air, and pulmonary edema.

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According to Chris Cabell, chief medical officer and senior vice president of Arena’s, “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”.

He further added, “We are pleased with the Fast Track designation and look forward to advancing this program as part of our cardiovascular focus.”

APD418 is a beta3- adrenergic receptor (AdrR) inhibitor and ‘cardiac myotrope’ for the heart condition. According to Arena Pharmaceutical’s website, “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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About Arena Pharmaceuticals Inc.

Arena Pharmaceuticals is a biopharmaceutical agency working to provide efficient and safe medicine for patients worldwide. With the main purpose to “deliver a robust pipeline of novel, transformational medicines is grounded in two decades of world class G-protein-coupled receptor (GPCR) discovery research”, the organization has been working since 1997.

Currently, Arena has small molecule drugs in development for possible clinical utility in multiple therapeutic areas. Along with APD418, the most advanced investigational clinical programs include APD811 or ralinepag for pulmonary arterial hypertension (PAH), APD334 or etrasimod – for inflammatory indications and APD371 for treatment of pain associated with Crohn’s disease.

“It is the breadth and depth of the portfolio, the prioritization of drug development to meet unmet patient needs, the strong financial health and the growing, bold-thinking world-class team that gives Arena the ingredients and passion to build a sustainable, vibrant next generation pharmaceutical company”.

About Food and Drug Administration (FDA)

FDA is a sub-agency of the US Department of Health and Human Services that is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, vaccines and medical devices. The agency also overlooks the safety and security of the nation’s food supply, cosmetics, and dietary supplements.


Mariyam Tanveer

Recently graduated from LUMS, I now work as Researcher and a Freelance Writer on Ask Health News

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