Advisory panel: Give OK to new diet drug

2 obesity treatments await FDA approval

The diet drug choices available to desperate dieters may be expanding soon.

A Food and Drug Administration advisory committee voted ( 18 to 4) Thursday to recommend approval of the new prescription diet drug lorcaserin. It marks the second obesity drug this year that the FDA advisory committee has recommended for approval. The agency often follows the panel’s advice but doesn’t have to. If both get the final green light, they could become the first obesity drugs approved in more than a decade. A decision on locaserin is expected by or on June 27.

Locaserin works on brain chemistry to create a feeling of fullness. It is supposed to be used in combination with a healthy diet and exercise.

Patients who started the locaserin trials lost an average of 5% of their weight; those who completed the studies lost an average of 8%, says company spokesman David Schull.

Another diet drug waiting for possible FDA approval is Qnexa ( kyoo- NEK- suh) from Vivus. On this medication, obese people lost 10% of their weight in combination with diet and exercise. The agency will announce its decision on Qnexa sometime on or before July 17.

Locaserin was rejected by an earlier FDA advisory panel in 2010 over safety concerns. The advisory committee that met Thursday discussed heart valve concerns but decided that the benefits of the drug outweighed the risks.

“There is concern about heart valve problems because of the way the drug works, but the preliminary trials show no increased risk,” says Abraham Thomas, chairman of the second advisory committee and an acting chair of the first committee. Thomas is head of endocrinology at Henry Ford Hospital in Detroit. “But there will need to be a larger study to confirm that the drug is safe.”

Sidney Wolfe, director of the health research group at Public Citizen, a consumer group, says he plans “a very strong letter” to the FDA advising the agency not to approve this drug. “We’ve already had a weight- reduction drug ( fenfluramine) taken off the market because it damaged heart valves, and it would seem reckless of the FDA to vote to approve another drug when there is concern about heart valve damage.”

But given the nation’s obesity crisis, with 42% of adults projected to be obese by 2030, “There’s a crying need for more obesity medication,” says Patrick O’neil, president of the Obesity Society, a group of weight- control researchers. “No single medication is going to be the answer . . . ”