Novo Nordisk (NYSE:NVO) said today that the FDA approved an updated label for its Saxenda liraglutide weight loss medicine. The therapy’s new label will include data showing that half of patients who received Saxenda and lost at least 5% of their weight after 56 weeks maintained their weight loss for 3 years.
The update is based on data from the company’s Scale obesity and pre-diabetes 3-year trial, which evaluated the long-term safety and efficacy of Saxenda in 3,731 adults.
All of the study’s participants were treated for 56 weeks and 2,254 patients with pre-diabetes were treated for 160 weeks. Patients were divided in a 2:1 ratio into the Saxenda arm or the placebo branch.
After 160 weeks, 50% of patients in the Saxenda arm lost at least 5% of their body weight, compared to 43% of patients in the placebo arm.
The data from this long-term study are consistent with Saxenda’s established safety profile, according to Nordisk. The medicine’s most common side effects were gastrointestinal.
“We are pleased by the FDA’s approval, which marks Saxenda as the only weight-loss and management medicine in a pen supported by long-term safety and efficacy data. The addition of this clinical data to the Saxenda label underscores Novo Nordisk’s dedication to building a robust body of scientific evidence, highlighting the chronic, progressive nature of the disease of obesity,” VP & chief medical officer Dr. Todd Hobbs said in prepared remarks. “We continue in our long-term commitment to improve the lives of people with obesity by partnering with the community on education and advocacy, increasing access to care, and advancing medical management of the disease.”