Label updates for Tresiba and Victoza backed by EMA committee

The European Medicines agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions for expanded use of Danish diabetes care giant Novo Nordisk’s (NOV: N) Tresiba (insulin degludec) and Victoza (liraglutide) in type 2 diabetes.

Once the European Commission approves the label expansion, physicians will be able to prescribe Tresiba, the once-daily, long-acting basal insulin in combination with GLP-1 receptor agonists, such as Victoza. Similarly, Victoza, the once-daily human glucagon-like peptide-1 (GLP-1 analogue), can be prescribed in combination with a basal insulin.

Tresiba was approved in Europe in 2013 for once-daily use in adults with type 1 and type 2 diabetes as a monotherapy and in combination with oral anti diabetic (OAD) medicinal products or with mealtime insulin1. Victoza was approved in Europe in 2009 for the treatment of type 2 diabetes in adults in combination with OADs2. Sales of Victoza were up 23% at 11.63 billion Danish kroner ($2.17 billion) in 2013.

"This is excellent news for patients with type 2 diabetes and their physicians. The update expands the options physicians have to individualise therapy for their patients and help them achieve glycemic targets, especially if they have concerns about hypoglycemia and weight gain," said Chantal Mathieu, a professor at Katholieke Universiteit Leuven, Belgium, the lead study investigator of the BEGINT: VICTOZA ADD-ON trial.