Consumer group urges FDA to reject Arena diet drug

Tue Jun 26, 2012 5:48pm EDT

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(Reuters) - Watchdog group Public Citizen urged U.S. regulators on Tuesday not to approve Arena Pharmaceuticals Inc's experimental diet pill lorcaserin, citing concerns it could increase patients' risk of heart valve damage.

The U.S. Food and Drug Administration is expected to rule on whether to approve the drug by Wednesday.

Public Citizen, a nonprofit consumer advocacy group, said physicians at last month's FDA advisory panel meeting on lorcaserin raised serious concerns about evidence of increased valve disease risks in patients who used the drug in clinical trials. The panel of independent experts voted 18 to 4 to recommend approval of the pill despite the concerns.

If approved, lorcaserin would become the first new diet drug on the U.S. market in more than a decade.

Heart valve problems were among the issues that led FDA to pull the anti-obesity drug known as fen-phen from the market in 1997, Public Citizen said.

The group also noted that FDA's panelists were concerned about the modest weight loss associated with lorcaserin.

A spokesman for Arena declined to comment on Public Citizen's concerns and said the company is focused on preparing for the FDA decision.

An FDA spokeswoman declined to comment and said the agency would respond directly to Public Citizen.

Arena's pill is one of three new potential obesity treatments vying to gain U.S. approval. Vivus Inc and Orexigen Therapeutics Inc are also trying to get pills approved.

Vivus in February won backing for its pill Qnexa from the same advisory panel that voted in favor of lorcaserin. The FDA pushed back its final decision on Qnexa to July 17 to review the company's risk evaluation plan for the drug.

The FDA first rejected lorcaserin, which is being developed in partnership with Japanese drugmaker Eisai Co Ltd, in October 2010, citing potential cancer risks. Arena resubmitted its application with more data to show that the previous findings of tumors in rats did not apply to people.

At the May advisory meeting, most panel members said side effects from lorcaserin could be addressed in post-approval studies and suggested patients who take the drug should get regular echocardiograms.

The panelists said overweight and obese patients needed more options.

Arena's lorcaserin was designed to block appetite signals in the brain in a similar way to fen-phen. Another diet pill, Meridia, was withdrawn in 2010 after also being linked to heart problems.

Arena's stock plunged 15 percent last Friday in what some traders attributed to profit-taking ahead of the FDA's decision. At one point during the day it had shed a third of its value. The stock has appreciated more than 400 percent this year in anticipation of a favorable ruling.

Arena shares fell 3.8 percent on Tuesday to close at $8.85 on Nasdaq.

(Reporting by Susan Kelly in Chicago; Editing by Matthew Lewis, Richard Chang and Tim Dobbyn)

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Comments (3)
Lorcaserin decreases heart rate and decreases your chance of having valvulopathy as seen in the BLOSSOM study. Patients with preexistent valvulopathy increase in mitral or aortic FDA-defined valvulopathy at week 52:

Lorcaserin 10 mg twice daily: 12% (preexistent valvulopathy was 5.2%)
Lorcaserin 10 mg daily: 11.1% (preexistent valvulopathy was 3.9%)
Placebo: 30.6% (preexistent valvulopathy was 4.1%)

As you can see, Lorcaserin not only does not cause valvulopathy but it is more beneficial for patients with preexistent valvulopathy

Jun 26, 2012 5:03pm EDT  --  Report as abuse
The 5-HT2B receptor is expressed in the heart; activation of this receptor is thought to underlie the valvular heart disease associated with such agents as fenfluramine, ergotamine, and pergolide.2, 20, 21, 44, 45 A comprehensive echocardiographic monitoring program initiated during Phase 2 was continued through Phase 3 clinical trials to evaluate possible changes in valvular function or morphology. Mulitiple analyses of over ~21,000 echoes from ~7800 patients in the Phase 3 program suggests that at the recommened clinical dose of 10mg twice daily, lorcaserin is not associated with valular heart disease.

Jun 26, 2012 5:09pm EDT  --  Report as abuse
Never before have I seen a hedge fund pay a “Non-profit” to release negative press on a drug the day before it is to be approved. This just goes to show how ruthless wall-street really is.

Jun 26, 2012 5:18pm EDT  --  Report as abuse
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