The future for overweight Americans who are seeking medical intervention but would rather not have extensive surgeries, such as gastric bypass or lap band surgery, may have a bit of hope on the horizon; as a U.S. Food and Drug Administration panel has endorsed another diet pill this year.
The panel voted 18-to-4 to approve the prescription diet drug Lorcaserin. It’s the second diet pill to be endorsed by an FDA advisory panel this year and, if approved, would be first new weight-loss drug in more than a decade.
Lorcaserin, made by Arena Pharmaceuticals, is actually one of three diet drugs currently seeking FDA approval — all of which were initially turned down in 2010 and 2011. Earlier this year, on its second attempt to win approval, competitor Vivus’ Qnexa received a favorable FDA panel vote. Although Orexigen’s Contrave, which was given the go ahead from an FDA advisory panel in 2010 it was ultimately rejected by the agency, will need additional long-term data on potential heart attack and stroke risks before the agency will reconsider it.
Lorcaserin was originally turned down in 2010 over FDA scientists’ concerns that the drug carried heart-valve risks, which is a reoccurring problem that has also plagued the weight-loss drug fenfluramine, which was taken off the market. It also showed increased breast and brain tumor development in animal studies.
A new review of Lorcaserin by the FDA concluded that there was only a “negligible risk” of cancer and that preliminary trials showed no increased heart-valve risk, but the panel said that more study would be needed.
However, the panel concluded that Lorcaserin’s benefits outweighed its potential risks when used long-term in overweight and obese patients. The drug, which is meant to be used in combination with a healthy diet and exercise, triggers weight loss by influencing brain chemistry and giving dieters a feeling of fullness.
In clinical trials, patients who used Lorcaserin lost an average of 3.1% of their starting weight over a year — a modest loss. About 38% of patients lost at least 5% of their body weight, compared with 16% in the placebo group, a result that met the FDA’s standard for effectiveness. In contrast, users of Qnexa lost an average 11% of their starting weight, and more than 83% of patients lost at least 5%, the Associated Press reports.
The drug is intended to be used in patients who are obese (with a BMI of 30) or greater or those who are overweight (BMI of at least 27) and have at least one weight-related health problem like high blood pressure.
“The advisory committee’s positive vote supports our belief in Lorcaserin as a potential new treatment option for the medical management of overweight and obesity,” Jack Lief, Arena’s president and CEO, said in a statement. “We will continue to work with the FDA as the agency completes its review of the Lorcaserin new drug application.”
The FDA approved Lorcaserin on June 27. The agency will decide on Qnexa by July 17.