ARTICLE | Clinical News

After PDUFA date passes, more data on Novo's liraglutide

November 5, 2014 2:46 AM UTC

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said 92% of obese, non-diabetic patients receiving 3 mg injections of liraglutide lost weight in the Phase III SCALE trial to treat obesity, compared with 65% of those on placebo. Patients on liraglutide also had greater average weight loss at 56 weeks than those on placebo (9.2% vs. 3.5%, p<0.0001).

Liraglutide is under review by FDA as an adjunct to diet and exercise for chronic weight management in adults with a BMI of at least 30 or in adults with BMI >27 with at least one co-morbidity. The PDUFA date was Oct. 20. Novo spokesperson Sharon Corbitt said the company has not received formal feedback from FDA but that Novo believes the agency is working to finalize the review. Liraglutide is also under review in Europe to treat obesity. ...