FDA OKs new prescription diet drug
The Food and Drug Administration approved the first new prescription diet drug in more than a decade Wednesday and may approve a second within a month.
For now, the FDA has approved lorcaserin, to be sold as Belviq (pronounced bel-veek), from Arena Pharmaceuticals. It works to create a feeling of fullness and can help people lose about 5% or more of their weight combined with a healthy diet and exercise. The medication is expected to be available in the first quarter of next year.
Lorcaserin is designed for people who are obese or overweight and have one weight-related health problem, such as type 2 diabetes.
The drug "will make the hard work of weight loss easier, but not effortless," says Gary Foster, an obesity researcher at Temple University in Philadelphia.
Lorcaserin was rejected by an FDA advisory panel in 2010 due to safety issues, but after a second meeting, committee members decided that the benefits outweighed the concerns about heart valve risks.
Sidney Wolfe, director of the health research group at Public Citizen, a consumer group, says lorcaserin doesn't promote much weight loss and exposes obese patients "to the added risk of damaged heart valves."
But the FDA says that there "was no statistically significant difference" in valve abnormalities between lorcaserin and placebo-treated patients.
Still, the drug's maker will be required to conduct six post-marketing studies, including a long-term cardiovascular trial.
By July 17, the FDA should decide on another diet drug, Qnexa (kyoo-NEK-suh) from Vivus. It helps obese people lose 10% of their weight.
If Qnexa is also approved, these two medications "will be complete game changers," says Tim Church, a researcher at the Pennington Biomedical Research Center in Baton Rouge and an adviser to Vivus.
"We are going to start treating (obesity) like a chronic disease. Insurance companies are going to start paying for these, and physicians are going to get extremely comfortable with these and other medications."
Arena's stock rocketed 28.7%, or $2.54, to $11.39 a share on volume of nearly 90 million shares Wednesday. Normally, about 21 million shares trade daily. Vivus surged 7.4%, up $1.94 to $28.33 a share.
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