Arena Obesity Drug Was Effective by ‘Slim Margin,’ FDA Staff Raises Rat Cancer Concern; Shares Tumble

9/14/10Follow @xconomy

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the secondary benefits patients experienced when they lost weight. “The weight loss observed in the lorcaserin-treated groups was associated with improvements in systolic and diastolic blood pressure, lipoprotein lipid levels, fasting glucose and insulin levels,” the FDA staff said.

In terms of safety, the FDA summary said that 2.66 percent of patients who got a 10 milligram, twice-daily dose of lorcaserin in the Bloom trial had a heart valve issue, compared with 2.35 percent who took a placebo. Both groups of patients, those on the drug and the placebo, had a 1.99 percent incidence of heart valve defects in the other major Arena trial, known as Blossom, the FDA said.

About twice as many patients on the Arena drug had some sort of neuropsychiatric effect, with dizziness, fatigue, and abnormal dreams among the most common. FDA reviewers said there didn’t appear to be a higher rate of depression-related adverse events on the Arena drug. The FDA staff did bring up some rare adverse events that could come up at Thursday’s discussion.

“Memory impairment, disturbance in attention, amnesia and other cognitive-related adverse events were reported infrequently overall; however, three times more subjects treated with lorcaserin 10 mg [twice daily] reported these types of events compared with subjects treated with placebo,” the FDA staff said.

The FDA’s deadline to complete its review of the Arena product is October 22.

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  • http://www.scoala-de-soferi.biz Scoala de soferi

    Rats showed malignant tumors from lorcaserin only at 57x and 84x the human dose, far above the 25x threshold the FDA uses. So is any rat cancer at any dose an “adverse event” even though it is nowhere near statistically significant relative to existing FDA guidelines? If so, every new drug will have to report a dose-limiting response of cancer or death in rats, because that’s how animal trials are done. I’m not sure why that is relevant to investors.
    It’s hard to see how fibroid tumors could be considered an “adverse event” because there is no relationship between fibroid tumors in rats and in humans.