It looks like Arena's weight-loss drug, Iorcaserin, is stepping closer to FDA rejection after the administration's advisory panel recommended denying the drug. The FDA will make the final decision Oct. 22.Another diet drug appears headed for a crash after failing to win the support of a U.S. Food and Drug Administration advisory panel. The panel of outside experts recommended rejection of Arena Pharmaceuticals's (ARNA) obesity treatment lorcaserin, saying the minimal efficacy doesn't justify the risks.

The decision is in keeping with the cautionary stance that FDA advisers have taken on other weight-loss drugs in recent months. On Wednesday, the panel delivered a split vote on whether to withdraw Abbott's (ABT) already marketed diet pill, Meridia, and in July, the panel voted against rival Vivus's (VVUS) obesity drug, Qnexa.

"These panels are setting a very high bar for obesity drugs," says Adam Feurstein of, who liveblogged the meeting.

The FDA doesn't have to follow its advisory panels' recommendations, but it usually does. The final ruling for Iorcaserin is scheduled for Oct. 22.

Panel: Risks Outweigh Benefits

The advisers' 9-5 vote, after a day-long meeting, echoed the sentiments expressed in the prepared analysis by the FDA reviewers. The outside experts were concerned about the possibility of cancerous breast tumors, even though they were found only in rats given high doses of the drug and not in humans. Basically, they thought the potential risks of the pill, when used by obese and overweight patients long-term, outweigh the potential benefits.

The company, not surprisingly, disagrees. "We believe that lorcaserin has a positive benefit-risk profile and represents a potential advance in the treatment of obesity," Arena CEO Jack Lief said in a statement. "We will work with the FDA as the agency completes its review of the lorcaserin new drug application."

The negative recommendation is no doubt a major setback for the small biotech company, which has no approved drugs. Trading on Arena shares was halted on Nasdaq during the meeting, but the stock had plummeted some 46% since Monday -- following the FDA reviewers' analysis -- and immediately dropped an additional 40% in after-hours trades Thursday to around $2.20 per share, down from Wednesday's close of $3.74 per share. This is one diet Arena could have done without.

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September 16 2010 at 8:11 PM Report abuse rate up rate down Reply

Using cancerous tumors found in overdosed rats as a basis to deny approval of a drug that has tested for this side-affect and found no tumors in HUMANS is ridiculous. While the results of taking the Arena drug might have been low it was enough to pass FDA standards and would have been better than nothing for the many obese people who also have diabetes. The FDA pulled the same rug out from under VIVUS, again expressing concern despite the fact that both of these drigs passed the clinical trials set buy the FDA. Millions of dollars have been spent bringing these drugs to the point of a final approval. Considering all the successful testing that has already been done this review should have been in the affirmative. Funny how a drug already on the market, Meridian, brought a split vote from this board and remains on the market. It was being reviewed becasue of actual prolems and still it got a better review. Could it be that major drug companies use their money and influence to get their drugs to market? This panel's decisions have financially killed these companies and caused job loss and the many investors also got a big hit. Shame on these FDA "Advisory Board nitwits.

September 16 2010 at 7:52 PM Report abuse +1 rate up rate down Reply