US FDA plans September panel meeting for Arena's lorcaserin
This article was originally published in Scrip
The US FDA has scheduled a panel meeting for Arena Pharmaceuticals' experimental anti-obesity drug, lorcaserin. The endocrinologic and metabolic drugs advisory committee is due to meet to discuss the therapy on 16 September.
Lorcaserin, a selective serotonin 2C receptor agonist, was filed in December last year, and has a PDUFA date of 22 October 2010 (scripnews.com, 23 December 2009). Only days after the filing, Vivus filed its anti-obesity drug Qnexa (topiramate and phentermine; scripnews.com, 30 December 2009), which has an FDA panel meeting scheduled for next month to discuss the drug. Orexigen, the third company racing for a slice of the obesity market, filed its drug Contrave (naltrexone SR plus bupropion SR) in April, but has yet to announce any panel meeting date (scripnews.com, 6 April 2010).
Some analysts have estimated that the obesity market could be as large as $125 billion. Given the size of the market, and the observation that side-effects led to drop-out rates as high as 50% from some clinical trial of these drugs, experts believe there is room for more than one therapeutic option (scripnews.com, 20 November 2009).
The broadness of the anti-obesity indication and the potential for misuse of any approved such drug, however, may drive the FDA to be particularly critical of the candidates' safety profiles. Other promising anti-obesity drugs, like Sanofi-Aventis's Acomplia (rimonabant), have previously been scuppered at a late stage due to safety concerns.