Eureka moment: US FDA approves first new obesity drug in 13 years

After several years of investigation, and a rejection by the US regulator, the Food and Drug Administration yesterday finally approved a new drug for the treatment of obesity, Belviq (lorcaserin; formerly given the brand name Lorquess), from San Diego, USA-based Arena Pharmaceuticals (Nasdaq: ARNA) - as an addition to a reduced-calorie diet and exercise, for chronic weight management.

Arena, which had already seen its share price rise ahead of the somewhat expected FDA decision, rose a further 29% to $11.39 by 4pm in New York. Last month, an FDA advisory committee recommended approval of Belviq by a vote of 18 to four (The Pharma Letter May 11).

Belviq, the first obesity management agent to be cleared by the FDA in around 13 year, is approved for use in adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia). Belviq works by activating the serotonin 2C receptor in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food. Compared with placebo, treatment with Belviq for up to one year was associated with average weight loss ranging from 3% to 3.7%.