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Amid Significant Unmet Need, What Magnitude of Efficacy and Safety Do Endocrinologists and Payers Expect of New and Emerging Therapies?

The evidence demonstrating the serious physical, economic, and societal effects of obesity is growing, and it has resulted in more-concerted efforts to confront this important public health issue. Lifestyle modifications, such as diet and exercise, are the cornerstone of obesity management but have limited efficacy. Bariatric surgery is by far the most effective treatment for obesity, but historically it has been restricted to severely obese patients. Pharmacotherapy aims to provide additional weight loss for patients for whom diet and exercise is insufficient or for whom surgery is not suitable or affordable. Unfortunately, the body’s innate predisposition to retain adipose tissue makes weight loss through pharmacological intervention very challenging. Moreover, several high-profile withdrawals of marketed antiobesity agents have occurred owing to serious adverse events. There is a significant market opportunity for novel prescription weight-loss agents, due to the scope of the epidemic. However, physician and regulatory caution has limited growth in the major markets we cover (United States, France, Germany, Italy, Spain, United Kingdom, and Japan), and the reimbursement environment for antiobesity agent remains challenging. This report aims to identify what physicians and payers are looking for in new prescription weight-loss agents and aims to better define the unmet needs relating to pharmacotherapy for obesity.

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