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.
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