FDA Grants Fast Track Designation for Decompensated Heart Failure Drug
The drug is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies.
On Jan. 16, 2020, Arena Pharmaceuticals announced FDA granted fast track designation for APD418, its β3-adrenergic receptor (AdrR) antagonist and cardiac myotrope for the treatment of decompensated heart failure (DHF).
Discovered and developed internally by Arena, APD418 is formulated to improve cardiac contractility with a reduced effect on heart rate, blood pressure, and myocardial oxygen consumption while potentially avoiding adverse events associated with current inotrope therapies, according to an Arena press release.
“With approximately 10 million DHF patient hospital visits expected in the [United States] 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, Arena's senior vice-president and chief medical officer, in the press release. "We are pleased with the [f]ast [t]rack designation and look forward to advancing this program as part of our cardiovascular focus."
Source: Arena
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.
