The opportunity for a weight loss drug to aid in the battle against obesity remains largely untouched especially with the decision by an FDA panel this week to reject, by a vote of 9-5, Arena Pharmaceuticals' lorcaserin, concluding that its benefits do not outweigh its risks.
Lorcaserin, an appetite suppressant that works in the brain (and potentially avoids the heart valve-damaging effects of another appetite supressant, fenfluramine, notoriously pulled from the market in the fen-phen combination), was considered safer. But the FDA panel ruled against it, citing more questions of uncertainty than identifiable risks.
Obesity has been furiously driving product development and clinical practice due to its burgeoning prevalence and its association with diabetes, cancer, heart disease, arthritis and others. A variety of surgical procedures like gastric bypass (e.g., Roux-en-Y anastomosis) and others with devices (stapling, lapband, gastric stimulation and others) are seeing growth in procedure volume and device sales. These approaches have demonstrated moderate success, and will likely continue to find favor even as alternatives to obesity-targeted drugs, but there is great recognition in clinical practice and the pharmaceutical industry that the obesity opportunity for drugs is persistently high and tantalizingly out of reach, even for the limited approved drugs. According to the WSJ:
[On September 15], the [FDA] advisory committee split down the middle on the issue of whether Abbott’s weight-loss drug Meridia, which has been on the market since 1997, should be pulled over concerns about cardiovascular side effects. In July, Vivus’s experimental diet drug Qnexa was rejected by the advisory committee. Another experimental weight-loss drug, Orexigen’s Contrave, will be weighed by the panel later this year.
An even more extensive list of drugs remain in the investigative, preclinical and clinical pipeline. It seems inevitable, one would think, that pharma companies would advance their development and learn sufficiently from, failed attempts, to bring a candidate to the FDA that will hit the mark.
In the meantime, the opportunity just keeps getting bigger and bigger…
See the (pending) September 2010 Report #S835 by MedMarket Diligence, "Products, Technologies and Markets Worldwide for the Clinical Management of Obesity, 2009-2019".