- FDA advisory committee votes 18-4 with one abstention in favor of approval
- The drug "behaves as an appetite suppressant," the maker says
- It is the second diet drug to win advisory committee approval
- The FDA does not comment on pending drug applications
A Food and Drug Administration advisory committee voted Thursday in favor of an investigational anti-obesity drug, putting it a step closer to winning the agency's approval.
The committee voted 18-4, with one abstention, in favor of approving lorcaserin, which would be sold under the brand name Lorqess if it receives full FDA approval.
The panelists, who met in Silver Spring, Maryland, said the data demonstrate that the potential benefits of lorcaserin outweigh the potential risks when used long-term in a population of overweight and obese individuals.
The panel included specialists in obesity and diabetes, pediatric endocrinologists, cardiologists and toxicologists.
According to Arena Pharmaceuticals, which developed the drug, Lorqess "behaves as an appetite suppressant which helps patients lose weight by essentially causing them to feel less hunger sensations."
It is the second obesity drug this year to pass this crucial step toward FDA approval. In February, an advisory committee voted 20-2 in favor of approving Qnexa, made by the California biopharmaceutical company Vivus Inc.
In 2010, advisory committees, citing safety concerns, failed to recommend either drug for approval. This year, both drug makers provided enough positive data to persuade the panels to support approval. Though the FDA often follows the recommendations of its advisory committees, that is not always the case. The FDA does not comment on pending applications.