Impact of FDA Guidance on Obesity Drug Development

The recent FDA guidance for obesity drug development has raised concerns among biotech companies. It emphasizes overall percentage weight loss as the primary endpoint, rather than considering the breakdown between fat mass and lean mass loss. This stance has disappointed some companies that focus on preserving muscle during weight loss. Additionally, Viking Therapeutics, a key player in obesity treatments, may face delays to its timelines due to the FDA's longer phase two trial requirements, complicating its advancement to phase three and challenging its market position.