EC approves Novo's Saxenda

Novo Nordisk A/S (CSE:NVO; NYSE:NVO) said the European Commission approved an MAA for Saxenda liraglutide for weight management as an adjunct to diet and exercise in obese adults or in overweight adults with at least one co-morbidity. The company plans to launch the drug in Europe this year.

FDA approved the human glucagon-like peptide-1 (GLP-1) analog in December to treat obesity. FDA's approval included a REMS and a boxed warning noting that thyroid C cell tumors were seen in rodent studies. Novo intends to launch Saxenda in the U.S. this half; spokesperson Mike Rulis declined to disclose its price (see BioCentury Extra, Dec. 23, 2014). ...