Victoza receives EU backing to treat cardiovascular risks in type 2 diabetes

An independent panel has announced its support for using Victoza (liraglutide) in Europe to reduce the risk of cardiovascular problems in people with type 2 diabetes
The Committee for Medicinal Products for Human Use (CHMP), under the European Medicines Agency (EMA) updated its stance on Victoza following results from a new trial.
The LEADER study involved 9,300 people with type 2 diabetes who were at high risk of major cardiovascular events. They were then treated with Victoza (liraglutide up to 1.8mg) or placebo for between 3.5-5 years.
Researchers studied the effects of the Victoza and found, combined with standard diabetes care, it reduced the risk of cardiovascular death, as well as non-fatal heart attacks and stroke by 13 per cent.
The CHMP panel voted unanimously positive when asked: “Do the results of LEADER establish that use of Victoza in patients with type 2 diabetes is not associated with excess cardiovascular risk?”
Todd Hobbs, vice president and US chief medical officer of Novo Nordisk, which manufactures the drug, said: “Cardiovascular disease is the number one cause of death for people with type 2 diabetes, and today’s discussion is an important reminder that there is an unmet need to provide benefits beyond HbA1c control in this population.”
The CHMP positive opinion for Victoza has now been referred to the European Commissio, which grants EU approval for final action on the proposed drug indication.
Novo Nordisk expects to receive the European Commission’s decision on whether the Victoza label will be expanded later this year.
Victoza is the second drug to be recommended for improving cardiovascular outcomes in people with type 2 diabetes in the EU. Earlier this year, the SGLT-2 inhibitor Jardiance (empagliflozin) became the first type 2 diabetes drug in Europe to include information about cardiovascular risk reduction on its label.