U.S. panel gives nod to new obesity drug
WASHINGTON — A panel of independent experts on Thursday urged the US Food and Drug Administration to approve the first new anti-obesity drug in more than a decade — Lorcaserin, made by Arena Pharmaceuticals.
The committee voted 18-4 in favor of the drug, which works to control the appetite through receptors in the brain, after trial data showed it helped nearly half of patients studied lose up to five percent of their body weight.
The drug was rejected in 2010 by the Endocrinologic and Metabolic Drugs Advisory Committee, which advises the FDA, over concerns that it formed breast tumors in rats.
However, those effects did not appear in trials on overweight and obese humans, and the 18-4 vote showed strong support that its benefits outweigh the risks.
The FDA does not have to follow the advice of its advisory panel though it often does.
Among those taking a 10 milligram dose of Lorcaserin, the most common adverse events were headache, dizziness, nausea, fatigue and dry mouth.
“It is not very impressive, the weight loss, but it is better than a placebo,” said Michael Aziz, an internist at Lenox Hill Hospital in New York City.
“However, when people stop the drug they gain the weight back.”
In February, FDA advisors also urged the approval of Qnexa, made by California-based Vivus. The same panel had also rejected Qnexa in 2010 over safety concerns.
Qnexa combines two existing drugs, the appetite suppressant phentermine and topiramate, an anti-convulsant that can be used in conjunction with other drugs for weight loss.
Some doctors already prescribe the combination as an off-label use for helping patients manage their weight.
Studies have shown dieters could lose up to 10 percent of their weight when taking the drug, along with regular exercise and following a healthy diet.
The FDA is set to decide on Qnexa in July. Its date for deciding on California-based Arena’s Lorcaserin is not yet known.
About two thirds of US adults are overweight or obese, according to US health authorities.