FDA Halts Amgen’s Phase 1 Obesity Drug Trial: AMG 513 Study on Hold
The FDA has placed a clinical hold on Amgen's Phase 1 study of its obesity candidate AMG 51312.
Amgen disclosed this information during its fourth-quarter earnings report23.
The company has not revealed the specific reason for the clinical hold but stated that they don't believe it's related to the medicine itself2.
Amgen is currently in discussions with the FDA to determine a path forward to reopen the study2.
This setback is considered a "speed bump" for Amgen's obesity R&D efforts, according to Raymond James analyst Gary Nachman2.
Amgen is also developing another obesity drug called MariTide, which is currently in late-stage testing2.
The mechanism of action for AMG 513 has not been disclosed by Amgen2.
This clinical hold occurs amidst Amgen's broader ambitions to become a significant player in the obesity treatment market1.
Sources:
1. https://endpts.com/amgen-announces-hold-on-ph1-obesity-candidate-pipeline-cuts/
2. https://www.biopharmadive.com/news/amgen-hold-amg-513-regeneron-dividend-advancell-series-c/739268/