Obesity Drug Developers Go With The Gut: R&D Hopes Focus On Locally Acting Agents
This article was originally published in Pharmaceutical Approvals Monthly
Developers remaining in the daunting weight loss space are pinning their hopes on a new wave of locally acting drugs with the hope that gut-selective mechanisms will show better efficacy combined with fewer safety concerns than the three centrally acting obesity candidates recently rebuffed by FDA.
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Development of a once-promising combination of pramlintide and metreleptin for obesity has been discontinued after a "commercial reassessment," U.S.-based Amylin Pharmaceuticals Inc. and Japan's Takeda Pharmaceutical Company Limited announced Aug. 4
Discontinuation is unrelated to prior safety suspension, say Amylin and Takeda, who acknowledge that "this is a difficult time for innovators and regulators."
The major lesson of FDA’s serial rejection of three obesity drugs in a six-month span is that safety is paramount in the weight loss space. That’s agreed. But beyond that, it’s tough to know what to expect, and obesity drug developers face an uncertain regulatory path going forward.