The Committee for Medicinal Products for Human Use (CHMP) issued positive opinions for expanded use of 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.
“This is excellent news for patients with type 2 diabetes and their physicians. The update expands the options physicians have to individualize therapy for their patients and help them achieve glycemic targets, especially if they have concerns about hypoglycemia and weight gain,” said Professor Chantal Mathieu, Katholieke Universiteit Leuven, Belgium, the lead study investigator of the BEGIN: VICTOZA ADD-ON trial.
The CHMP recommendation for both Tresiba and Victoza was based on efficacy and tolerability data from four Phase 3 clinical trials. All four trials were conducted in adults with type 2 diabetes.
Date: March 21, 2014
Source: Novo Nordisk
Filed Under: Drug Discovery