HealthDay News — The FDA has approved the anti-obesity drug Belviq (lorcaserin hydrochloride, Arena Pharmaceuticals) — the first approval of a weight-loss drug in 13 years — for use in overweight and obese patients.
The drug is indicated for people aged 18 and older with a BMI of 30 or higher, or adults with a BMI of at least 27 who also have a weight-related condition, such as type 2 diabetes, hyperlipidemia or hypertension, the agency said in a news release.
Belviq is designed to activate the serotonin 2C brain receptor, which helps people feel full after eating less. The drug received approval after results from three randomized, placebo-controlled clinical trials involving nearly 8,000 overweight and obese people, showed that those who received Belviq as an adjunct to lifestyle modification had an average weight loss ranging from 3% to 3.7% compared with placebo. The drug was also associated with favorable changes in glycemic control among patients with type 2 diabetes.
Belviq’s approved labeling states that patients who fail to lose at least 5% of their body weight after 12 weeks of treatment should discontinue taking the drug.
Arena Pharmaceuticals will be required to conduct six post-marketing studies to measure the risk for myocardial infarction, stroke and other cardiovascular problems among patients taking the drug, the FDA said.
Common clinical side effects include headache, dizziness, fatigue, nausea, dry mouth and constipation. People with diabetes also are at greater risk of hypoglycemia, the agency said.