The FDA has been managing a streak of rejections for weight loss medications, including a panel vote against Arena Pharmaceuticals’ drug lorcaserin. Panelists raised concerns about tumors seen in rats in pre-clinical testing of the drug offset by only modest benefits. The vote is a major setback for San Diego-based Arena, which was hoping for their first product approval and to be the first of three competing products to market. In July, the same FDA panel voted against recommending approval for Vivus’s product Qnexa due to safety concerns. Orexigen Therapeutics will have its own drug reviewed at a meeting in December.
Following the vote, the panel chair, Dr. Abraham Thomas, suggested that the FDA raise the bar on weight loss drugs, of which there are only three approved in the US. Earlier in the week the same panel was split on whether to withdraw Abbott Lab’s diet pill Meridia, which has been linked to heart attack & stroke. European regulators banned the drug earlier this year.
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