FDA has weighed in on the latest weight-loss drug lorcaserin hydrochloride (Belviq), approving the Arena Pharmaceutical drug for use in adults with a body mass index (BMI) of 30 or greater and those with a BMI more than 27 and hypertension, type 2 diabetes or dyslipidemia.
The approval will add bulk to the rather thin obesity drug market that has been under scrutiny since the European Medicines Agency found the drug sibutramine, commonly found in obesity drugs, to have the potential to put patients at risk for cardiovascular events.
Belviq activates serotonin 2C receptors in the brain, helping patients to eat less and feel full after eating smaller amounts.
The FDA’s approval was based on an 8,000 patient, placebo-controlled trial that included obese and overweight patients, with and without type 2 diabetes. The patients were treated for 52 to 104 weeks and received lifestyle modifications that included a reduced calorie diet and exercise counseling. The trial found Belviq to be associated with an average weight loss ranging from 3 to 3.7 percent.
In addition, the trial showed that 47 percent of patients without type 2 diabetes lost at least 5 percent of their body weight compared with 23 percent of those treated with placebo. For type 2 diabetes patients, 38 percent of patients treated with Belviq lost at least five pounds of body weight compared with 16 percent treated with placebo.
While FDA approved the drug, the agency said that the drug label will recommend discontinuing the drug in patients who do not lose 5 percent of body weight after 12 weeks.
While FDA noted that weight-loss drugs fenfluramine (Pondimin, Ponderax and Adifax) and dexfenfluramine (Redux) were pulled from the market after the drugs were shown to cause heart valve damage, FDA said that the approved 10 mg dose of Belviq does not have that effect. A study assessed heart valve function in the 8,000 patients in the Belviq development program; however, it was not studied in patients with serious valvular heart disease.
Upon approval, Arena is required to conduct six postmarketing studies, including one that studies long-term cardiovascular outcomes to assess whether the drug has any impact on the risk of cardiac events.