FDA News

FDA: Long-term safety, efficacy data added to Saxenda product label

The FDA today approved an updated product label for liraglutide injection 3 mg to include long-term safety and efficacy data from the 3-year SCALE Obesity and Prediabetes trial, according to a press release from Novo Nordisk.

The SCALE trial investigated the long-term efficacy and safety of liraglutide (Saxenda, Novo Nordisk) in combination with a reduced-calorie meal plan and increased physical activity in adults with obesity or excess weight and at least one weight related comorbidity. Participants were assigned to liraglutide or placebo, and more participants assigned to liraglutide who lost 5% or more of their weight after 56 weeks (26% vs. 10% on placebo) were able to maintain the weight loss at 3 years (56% vs. 25%).

The most commonly reported adverse events were gastrointestinal and occurred more frequently in participants assigned liraglutide compared with placebo.

“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,” Todd Hobbs, MD, vice president and chief medical officer at Novo Nordisk said in the release. “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. 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.”

The FDA today approved an updated product label for liraglutide injection 3 mg to include long-term safety and efficacy data from the 3-year SCALE Obesity and Prediabetes trial, according to a press release from Novo Nordisk.

The SCALE trial investigated the long-term efficacy and safety of liraglutide (Saxenda, Novo Nordisk) in combination with a reduced-calorie meal plan and increased physical activity in adults with obesity or excess weight and at least one weight related comorbidity. Participants were assigned to liraglutide or placebo, and more participants assigned to liraglutide who lost 5% or more of their weight after 56 weeks (26% vs. 10% on placebo) were able to maintain the weight loss at 3 years (56% vs. 25%).

The most commonly reported adverse events were gastrointestinal and occurred more frequently in participants assigned liraglutide compared with placebo.

“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,” Todd Hobbs, MD, vice president and chief medical officer at Novo Nordisk said in the release. “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. 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.”