Memorandum

Tresiba and Victoza receive positive CHMP opinion for proposed expanded indications – March 27, 2014

Novo Nordisk announced recently that it has received positive opinions from the EMA's Committee for Medicinal Products for Human Use (CHMP) on a pair of indication expansions for the ultra-long-acting basal insulin Tresiba (insulin degludec) and the GLP-1 agonist Victoza (liraglutide). Specifically, the label expansions would approve the use of Tresiba in conjunction with a GLP-1 agonist (such as Victoza), and would approve the use of Victoza in conjunction with basal insulin (such as Tresiba). The recommended starting dose for Tresiba when added to a GLP-1 agonist would be 10 units (followed by individualized adjustments); when a GLP-1 agonist is added to existing Tresiba therapy, a 20% reduction in Tresiba dose is recommended (again, followed by subsequent dose adjustment). The final EMA decision (which we expect to also be positive) should arrive in the next month or two. Until now, for type 2 diabetes patients in Europe, Victoza was only approved as an add-on to oral agents, while Tresiba was allowed as an add-on to oral agents or mealtime insulin. We wonder if providers in Europe have been prescribing Victoza and Tresiba together off-label, since the two products have a very complementary profile of action (the former particularly effective at lowering postprandial glucose, and the latter effective at lowering fasting glucose levels). Indeed, this label expansion can be seen as a step by Novo Nordisk towards the much-vaunted IDegLira fixed-ratio combination of the two products (Dr. John Buse [University of North Carolina, Chapel Hill, NC] called IDegLira the "most powerful agent we have even contemplated in type 2 diabetes"). The drug (in the DUAL I phase 3 study) demonstrated a striking 1.9% A1c reduction compared to 1.4% with Tresiba monotherapy and 1.3% with Victoza monotherapy (from a baseline of 8.3%).