My apologies for beginning with some shameless self promotion: I will be live-blogging the Arena FDA panel, providing eight hours-plus of continuous, play-by-play coverage and instant analysis as obesity experts review and ultimately pass judgment on lorcaserin's efficacy and safety.
Don't miss out on all the excitement and suspense. More than 22,000 readers logged into my live blog of the Vivus (VVUS) FDA panel in February, which resulted in a 20-2 vote in favor of Qnexa. I expect another big crowd on May 10, so mark your calendars.
FDA has not yet announced the final roster for the upcoming Arena panel but five obesity experts have accepted invitations to participate, according to a memo posted to the agency's web site. One of these five obesity experts is Dr. Daniel Bessesen, a professor of endocrinology at the University of Colorado School of Medicine. Bessesen received a conflict of interest waiver to participate on the Arena panel because he's a member of a data safety monitoring board for a competing (but undisclosed) weight-loss therapy.The identities of the remaining four obesity experts invited by FDA to sit on the Arena panel have not been disclosed but the agency said one is a clinical endocrinologist (like Bessesen); the others are a bariatrician, a pediatric endocrinologist and epidemiologist. These five obesity experts will beef up the 10 sitting experts on the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC), six of whom are also endocrinologists or have relevant expertise in diabetes and obesity. Key question for next week: Does an FDA panel stacked heavily with obesity drug experts help or hurt lorcaserin's chances for a positive vote? Eight endocrinologists/obesity experts sat on the Vivus FDA panel in February, with all but one voting to recommend Qnexa's approval. The overall panel vote was 20-2 in Qnexa's favor. Qnexa won in large part because treatment led to significant, clinically meaningful weight loss, which outweighed the potential risk of causing birth defects in children born to women using the two-drug therapy.
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