An FDA panel on Thursday voted 9-5 that the benefits of Arena Pharmaceuticals and Eisai's experimental weight loss drug, lorcaserin, did not outweigh its safety risks "when used long-term in a population of overweight and obese individuals." Panelist Jessica Henderson noted "I do think (lorcaserin) is promising, but there's too much uncertainty at this time."
Echoing concerns raised in FDA staff documents released ahead of the meeting, panelists raised concerns about cancer risks associated with the drug after tumours were observed in studies involving rats given high doses of lorcaserin. No such increased risk was observed in human trials of the drug. Despite the verdict, a number of panel members said lorcaserin was promising and encouraged Arena to keep studying the drug to rule out uncertainties.
Commenting on the vote, Arena CEO, Jack Lief, said the company and marketing partner Eisai "believe that lorcaserin has a positive benefit-risk profile."
An FDA decision on the drug is expected by October 22. Analysts predict that if approved, lorcaserin could have peak annual sales of $822 million. In July, the same FDA panel voted against recommending approval for Vivus' weight loss drug Qnexa (phentermine/topiramate) due to safety concerns. In addition, Orexigen Therapeutics' obesity treatment Contrave (bupropion/naltrexone) is scheduled to have its agency panel review in December.
--Reference Articles
Arena and Eisai provide update on lorcaserin FDA Advisory Committee Meeting - (Arena Pharmaceuticals)
Arena fails to win US panel’s backing for obesity treatment - (Bloomberg)
FDA panel rejects diet drug lorcaserin - (Chicago Tribune)
FDA briefing document - (FDA)
US advisers reject Arena diet drug - (Forexyard)
FDA panel rejects diet pill - (The New York Times)
FDA panel rejects Arena's weight-loss drug lorcaserin (free preview) - (The Wall Street Journal)
FDA panel says 'no' to experimental diet pill - (The Washington Post)
FDA panel votes no on Arena Pharmaceuticals' locaserin drug - (TheStreet.com)
Arena Pharmaceuticals obesity drug shot down by FDA panel - (Xconomy)
**Published in "First Word"
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