The pharma race to develop increasingly more potent incretin-based therapeutics-what is for the clinicians to know

Abstract

In this Commentary, we highlight the following issues concerning the development of increasingly more powerful incretin-based therapeutics (IBT) that to date have not been addressed with the attention they may deserve: 1. The appropriateness of BMI-based inclusion criteria for a drug capable of producing weight loss approaching that seen after bariatric surgery; 2. significant limitations inherent in communicating the results of an obesity trial involving a potent IBT; 3. the one-size-fits-all dosing strategies in trials may introduce new challenges for sponsors in the race to develop increasingly powerful IBT; 4. the currently imposed limitations on what can be communicated in the approved IBT product label create an advantageously unlevel playing field for opportunists such as compounding pharmacies. Proposals on how to address these issues are made in the text. While it is realized that the presented topics and solutions are not without controversy, they are intended to provoke further discussion.

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