Published February 02, 2012
An FDA advisory committee will meet in the second quarter to discuss Arena Pharmaceutical Inc's experimental obesity drug following the company's recent resubmission of an application seeking its approval, Arena said on Wednesday.
Arena's lorcaserin, which is being developed in partnership with Japanese drugmaker Eisai Co Ltd, was one of three new potential weight loss drugs rejected by the Food and Drug Administration over safety concerns.
Arena resubmitted its new drug marketing application to the agency last month after providing new data to health regulators that it believes will alleviate concerns about cancerous tumors found in rats used in animal studies of lorcaserin.
Obesity, a leading cause of diabetes, heart disease and other serious health problems, has reached epidemic proportions in the United States. But the FDA has set a very high approval bar for weight loss drugs because such a large portion of the general population is likely to want to take them.
Many industry observers believe approval of any new weight loss drug remains a longshot. But the FDA is likely to give serious consideration to any recommendation by its advisory panel of experts.
Vivus Inc and Orexigen Therapeutics Inc are also working to convince the FDA of the worth of their weight loss drugs after initial rejections.