FDA Panel Gives Nod to New Diet Drug Lorqess


Weight Loss Drug: Weighing Risks, Benefits

Despite the weight loss not being that impressive, many of the doctors on the panel as well as doctors and patients present at the meeting said another weight-loss tool is sorely needed in the fight against obesity.

"We need a broader array of tools, something between cutting calories and cutting the GI tract," Dr. Domenica Rubino, an endocrinologist and director of the Washington Center for Weight Management, told the panel.

One woman, Lisa Sutter, of Washington, told the panel that she was always of normal weight until after she had two children and then found it impossible to get her weight under control. She enrolled in the Lorqess trial in 2007, and soon she found her urges to overeat had all but disappeared.

"My brain switched back to normal again," she said.

She lost 40 pounds in a year. But after she stopped the drug, she gained it all back, and more.

"I don't want to be this fat forever," she told the panel. "Please, I implore you to approve this drug."

When the panel's vote was announced, Sutter quietly wept, grateful that she might have the option to go back on Lorqess.

While the FDA is not required to follow the advice of its clinical trials, it often does.

The company expects to get a decision from the FDA by June 27.

Lorqess is one of three weight-loss drugs vying to be the first new diet drug approved in a decade.

The FDA is expected to make a decision on Qnexa -- a low-dose combination of phentermine and topiramate -- in July. Like Lorqess, Qnexa was at first rejected by the FDA, but Vivus, the manufacturer of Qnexa, submitted new data on the drug's psychiatric and cardiovascular side effects and an FDA advisory committee endorsed approval by a 20-2 vote in February.

The makers of the third weight-loss drug, a naltrexone/bupropion combination pill called Contrave, announced in 2011 that it won't market Contrave in the U.S. because the FDA's additional requests for data are too burdensome.

The FDA is being particularly vigilant before approving new anti-obesity drugs because if approved, they would likely be very widely used given the nation's obesity epidemic.

New data presented this week at the CDC's Weight of the Nation conference estimated that about 42 percent of adults will be obese by 2030.

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