The US Food and Drug Administration (FDA) has granted approval to Novo Nordisk‘s Victoza (liraglutide), a once-daily injection to treat type 2 diabetes in some adults.
Victoza is in a class of medicines known as glucagon-like peptide-1 (GLP-1) receptor agonists, which help the pancreas make more insulin after eating a meal.
The treatment is intended to help lower blood sugar levels along with diet, exercise and selected other diabetes medicines and is not recommended as an initial therapy.
FDA Division of Metabolism and Endocrinology Products director Mary Parks said that diabetes is a leading cause of death and disability, with more than 1.5 million new cases diagnosed annually.
“Controlling blood sugar levels is very important for preventing or reducing the long-term complications of diabetes, and Victoza offers certain patients a treatment option for controlling their blood glucose levels,” Parks said.
The efficacy of Victoza was established during five clinical trials involving more than 3,900 people, where the most serious risk noted was a predisposition to pancreatitis for patients who took Victoza rather than in patients taking other diabetes medicines.
Other common side effects observed with Victoza were headache, nausea and diarrhoea. Other side effects included allergy-like reactions such as hives.
Victoza was not associated with an increased risk for cardiovascular events in people who were mainly at low risk for these events. The FDA has, however, placed several post-marketing requirements in effect, including a cardiovascular safety study.