Reviewers say liraglutide effective for obesity

FDA reviewers said 3 mg liraglutide from Novo Nordisk A/S (CSE:NVO; NYSE:NVO) is effective as an adjunct to diet and exercise for chronic weight management in adults with obesity or who are overweight with co-morbidities. However, the reviewers said there are safety concerns with the long-acting analog of glucagon-like peptide-1 (GLP-1), including some known with lower doses of liraglutide that Novo already markets in the U.S. for Type II diabetes. Safety issues highlighted by the reviewers include increased rates of pancreatitis; neoplasms, including medullary thyroid cancer (MTC) and a numerical imbalance of breast cancer; and increased heart rates.

The comments came in Victoza to treat Type II diabetes. The approved label includes a REMS and black box warning on the risks of pancreatitis and MTC. ...