The biggest concern expressed by the experts on Thursday's FDA panel was the risk that long-term use of lorcaserin could cause heart-valve damage, or valvulopathy. Arena presented data Thursday showing, mechanistically, lorcaserin doesn't hit receptors that cause heart valve problems; and FDA concurred.
Experts on the panel were less convinced, particularly since the clinical data collected to date on lorcaserin could not rule out an increased risk of valvulopathy. Importantly, none of the panel experts, including the cardiologists, demanded that Arena be required to rule out a lorcaserin-valvulopathy link prior to the drug being approved.
Dr. Bill Hiatt, a cardiologist from the University of Colorado School of Medicine, was notable during panel deliberations advocating strongly for the conduct of a post approval cardiovascular outcomes trial of lorcaserin. Hiatt's argument seemed to blunt a more cautious stance taken by Dr. Sanjay Kaul of Cedar-Sinai Heart Institute, who voted against lorcaserin although eventually conceding, too, that a post-approval heart safety study was appropriate.
Setting parameters for a lorcaserin post-approval safety study could be another item that delays the drug's approval.
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