The FDA has posted the briefing documents for the September 16 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee that will consider the NDA for the diet drug lorcaserin (Lorqess, Arena).
The FDA reviewers agree that the drug met the predetermined measure of efficacy, though only by a slim margin. After briefly skimming the documents I couldn’t find any serious safety concerns raised by the FDA, though there is a lot of discussion about cancers in rats and mice.
Investors in Arena appear to be nervous, however. Following the posting of the review documents Arena’s stock price plummeted by more than 40% at the start of the day’s trading.
One interesting note: one panel member is Heidi Connolly from the Mayo Clinic. Readers with a long memory may recall that she was the first author of the initial report in the New England Journal of Medicine that first raised concerns about the association of valvular disease with phen-fen in 1997.
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