The US Food and Drug Administration has approved Arena Pharmaceutical's weight-loss pill lorcaserin, the first new weight-loss pill in 13 years.
Once cleared by the Drug Enforcement Administration, lorcaserin will be marketed by Arena in the US under the commercial name Belviq, to aid chronic weight management in patients with a BMI greater than 30, or those with a BMI in excess of 27 and suffering from high blood pressure, elevated cholesterol or type 2 diabetes.
Despite the approval, the FDA was quick to warn consumers that the safety and efficacy of Belviq when used alongside other diet medications had not been established and that the long-term risk of heart attack or stroke when taking the drug has yet to be verified.
Belviq has worried US regulators in the past, having previously been rejected in 2010 due to concerns relating to the development of tumours in rats that were given the drug. An FDA advisory panel also raised concerns regarding evidence of an increased risk of heart valve disease in patients who participated in clinical trials.
Whilst the FDA moved to quash links to heart valve disease, stating that Belviq did not appear to carry that risk, side effects including depression, migraine and memory lapses have been recorded.
Doctors have urged regulatory bodies to approve new weight-loss medications in a bid to halt the growing obesity rate in the US, which is contributing towards a rise in associated healthcare costs. Until now the FDA has resisted, establishing a strict criteria for vaunted weight-loss pills to meet before approval.
Arena Pharmaceutical's lorcaserin vied with three other medications, Vivus' Qnexa and Orexigen's Contrave, to become the first new weight-loss pill on the market, and Arena has certainly stolen a march on its rivals with this approval.
Arena expects to launch Belviq in 2013.