Question of the Month - October 2010

Q: What ever happened to that new weight loss drug at the FDA??? Was there a decision made???




A: What looked originally like smooth sailing for lorcaserin (Lorquess) became a huge discussion in the expert advisory panel. Questions revolved around AVERAGE weight loss (efficacy) and side effects in rats. It was surprising for me to hear usually unbiased FDA representatives adding descriptive language to ("marginal") effectiveness and a surprising lack of an oncology/oncogenic expert at the panel meeting itself. Turns out that when the drug is given in a huge dose to rats, it lead to tumors. The discussion from the committee members revolved around confusion about the relationship between tumors in rats and tumors in humans and no one seemed to know the answer.

In short, the FDA quoted safety concerns relative to benefits in rejecting the drug for now. Apparently the company (Arena Pharmaceutical) will meet with the FDA shortly to talk about the "more information/further studies" needed to clear up the present confusion.

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