FDA Panel Recommends Arena’s Obesity Drug Lorcaserin

An agency advisory panel voted 18–4 with one abstention Thursday in favor of approval for Arena’s weight-loss drug lorcaserin. But panelists stressed the need for postmarket surveillance to monitor risks, particularly heart events.

Despite the favorable vote, many Endocrinologic and Metabolic Drugs Advisory Committee members expressed some degree of hesitation. Most said the drug met the agency’s efficacy standards, though the magnitude of weight loss was modest.

Panelists said a risk evaluation and mitigation strategy, along with postmarket trials, should be required to rule out a risk for valvular heart disease as well as other adverse cardiac events and to mitigate lingering safety concerns and gaps in current data.

A few panelists also expressed concerns about potential cancer events, though the majority seemed satisfied by new rat tumor studies presented by the sponsor.

Lorcaserin wasn’t so fortunate its first time around. The drug was voted down at its initial panel meeting, and other drugmakers are seeing advisory committee disappointments as well.

The climate inside the FDA has never been more challenging for companies seeking new product approvals. Problems with safety, efficacy and unexpected side effects of approved products have put the agency on high alert. The result is tougher reviews, more questions and — most importantly — more rejections. Failure to anticipate even the smallest details can cost your company tens of millions, or even hundreds of millions of dollars, and damage your reputation.

Finally, there is one book that provides all the tools you need to prepare for an FDA advisory committee meeting, from detailed timelines and messaging tips to rules for crafting effective slides and handling the toughest questions: FDAnews’ The FDA Advisory Committee Survival Manual.      
This report walks you through the entire advisory committee process, from the earliest stages of preparation through essential critiquing and refining of presentation materials … from understanding who sits on advisory committees and how they operate to rehearsing your presentation … and concluding with practical guidance for the days after the presentation.

Be a shining star at your next advisory committee meeting by ordering this book today.