The FDA today approved the first generic referencing the glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide (Victoza), an 18 mg/3 mL injection, to improve glycemic control in patients aged 10 years and older with type 2 diabetes.1 The treatment is indicated as an adjunct to diet and exercise.
Liraglutide injection was initially approved for adults with type 2 diabetes in 2010, with an expanded indication in 2019 including children and adolescents aged 10 to 17 years.2 It was the first GLP-1 receptor agonist approved for children and adolescents with type 2 diabetes, and its approval marked the first new treatment option for this age group in 19 years.
Due to ongoing shortages of liraglutide injection and other GLP-1 agonists, generic drug applications for drugs in this area are a priority, according to a press release from the FDA announcing the approval.1 The first generic in this class of medications to earn FDA approval, a generic referencing exenatide (Byetta), was approved in November 2024.
“The FDA supports development of complex generic drugs, such as GLP-1s, by funding research and informing industry through guidance as part of our ongoing efforts to increase access to needed medications,” Iilun Murphy, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in a statement.1 “Generic drugs provide additional treatment options which are generally more affordable for patients. Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”
Nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation were the most commonly reported adverse events in clinical trials for liraglutide injection, according to the release. The approved generic liraglutide also includes a boxed warning for an increased risk of thyroid C-cell tumors, meaning those who have had medullary thyroid carcinoma or whose family members have should not use liraglutide. Patients with multiple endocrine neoplasia syndrome type 2 should also not use liraglutide.
References
1. FDA approves first generic of once-daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes. News release. FDA. December 23, 2024. Accessed December 23, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes
2. FDA approves Victoza for the treatment of type 2 diabetes in children and adolescents aged 10-17 years. News release. Novo Nordisk. June 17, 2019. Accessed December 23, 2024.
