FDA Panel Okays Arena Diet Pill

FDA Panel Okays Arena Diet Pill

May 14th, 2012 // 1:10 pm @


In a move that may herald a new era in fighting fat, an FDA advisory panel this afternoon voted 18-to-4 to recommend the agency approve the Arena Pharmaceutical diet pill, which is known as Lorqess. This marks the second time in three months that an FDA panel has decided the benefits of reducing the growing American waist line outweigh the various risks that have delayed this latest round of fat-fighting drugs from finding their way to medicine cabinets.

In February, an FDA advisory committee voted overwhelmingly in favor of the Qnexa diet pill developed by Vivus. Of course, the recommendations are not a guarantee the FDA will issue approvals. But the back-to-back endorsements – and lopsided votes – suggest the safety concerns that plagued the drugmakers during earlier panel meetings have been sufficiently addressed and increase the odds the FDA will approve the pills.

Unlike the September 2010 advisory panel meeting, Arena was able to overcome concerns about a theoretical risk of an increase in cancer; valvulopathy, which is heart valve damage, and cardiovascular adverse events. Some committee members discussing the possbility of requiring echocardiograms before patients are prescribed Lorqess, given that an increased risk CV events could not be ruled out. Most likely, the FDA would require a post-approval outcomes study.

A related question is whether the FDA would require a REMS, or Risk Evaluation and Mitigation Strategy. A REMS was proposed for Vivus pill, but a key issue with that drug is the risk of birth defects, which does not plague the Arena pill. Nonetheless, the FDA has been consistently cautious in viewing diet pills because these drugs are likely to be widely and, perhaps, inappropriately used, suggesting REMS programs are likely to be employed.

Nonetheless, fighting fat is a key priority for public health agencies. The percentage of obese Americans, which is already a hefty 36 percent, is expected to swell to 42 percent by 2030. And by then, 11 percent could be severely obese, which is deemed to be about 100 or more pounds over a healthy weight, compared with 6 percent two years ago, according to a study released earlier this week in the American Journal of Preventive Medicine (read here).

However, one public health advocate says the FDA bent overbackwards toward this end. Diana Zuckerman, who is president of the National Research Center for Women & Families, a nonpartisan, nonprofit think tank, says the FDA’s Center for Drug Evaluation & Research “has been under pressure to approve more drugs to reduce obesity. The pressure is from the many groups focused on reducing obesity. Their mantra has been that the risks of obesity are much greater than the risks of these drugs.”

“The consumer and public health advocates, in contrast, point out that the benefits of these drugs are very limited. Study after study show that many patients stop taking the drugs after a few weeks or months, and even those they stay on for six months or more tend to stop taking the drugs as soon as the benefits plateau. Then, they gain the weight back again. In other words, the drugs have the same long-term impact as yo-yo dieting,” she writes us.

Lorqess “did not meet the weight loss standards that FDA requires, and has risks of suicidal thoughts, neurological problems and possibly breast cancer. CDER knew their usual Advisory Committee was unlikely to recommend approval, so the agency added more clinicians,” she concludes. “The clinicians almost always want ‘more options’ and voted to recommend approval for this ineffective, possibly dangerous drug.”

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