An experimental obesity pill from Arena Pharmaceuticals won the support of U.S. advisers on Thursday, as public health advocates push for new solutions to the nation's growing obesity epidemic.
A panel of outside experts to the U.S. Food and Drug Administration voted 18 to 4 to recommend approval of lorcaserin, bringing the drug a step closer to U.S. approval as one of the first new weight-loss treatments in over a decade.
Lorcaserin is Arena's most important product.
Shares of Arena , which were halted pending the panel vote, nearly doubled in value to $6.92 after closing at $3.66 on Wednesday.
Arena's pill is one of three new potential obesity treatments vying to gain U.S. approval and be the first new weight-loss treatment on the market after initial rejections over safety issues.
The FDA first rejected lorcaserin, which is being developed in partnership with Japanese drugmaker Eisai Co., in October 2010, citing potential cancer risks.
Arena resubmitted its application with more data after the 2010 rejection to show that the previous findings of tumors in rats did not apply to people, which seemed to soothe some of the FDA's concerns.
The advisory committee members still had some concerns about side effects, especially uncertainty about heart valve problems, but most said these concerns could be addressed in post-approval studies.Page 1 of 4 | Next Page