FDA panel backs liraglutide for obesity

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend approval of 3 mg liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) as an adjunct to diet and exercise in adults with a BMI of at least 30 or in adults with a BMI greater than 27 with at least one co-morbidity. The PDUFA date is Oct. 20.

Panel members were satisfied with the efficacy data, noting that in Phase III trials the compound met FDA's efficacy benchmark for obesity therapies: at least a 5% placebo-adjusted weight loss, or at least twice as many patients in the treatment arm losing at least 5% of body weight vs. placebo. ...