Obesity Drug Developers Aim To Navigate Regulatory Backroads
This article was originally published in Pharmaceutical Approvals Monthly
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.
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Arena and Eisai expect to hear in the next week or so whether FDA will accept their answer to an October 2010 “complete response” letter and set a new action date for their novel weight loss drug.
GlaxoSmithKline includes the alli weight-loss brand in its planned divestment of international OTCs worth about $813 million in 2010 sales, or 10% of the firm's total Consumer Healthcare business.
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.