FDA approves first generic of once-daily GLP-1 agonist for T2DM

December 25, 2024

On December 23, FDA approved the first generic referencing Victoza (liraglutide injection) 18 mg/3 mL, a GLP-1 receptor agonist indicated to improve glycemic control in adults and pediatric patients ≥10 years of age with type 2 diabetes as an adjunct to diet and exercise.

The agency approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide), which is administered twice daily.

According to the FDA press release, liraglutide injection and certain other GLP-1 medications are currently in shortage. The agency says it prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access.

The prescribing information for the generic liraglutide injection includes a Boxed Warning about the increased risk of thyroid C-cell tumors. Patients who've had, or have family members who've ever had medullary thyroid carcinoma shouldn’t use liraglutide, nor should patients who have multiple endocrine neoplasia (MEN) syndrome type 2. Liraglutide also carries warnings about pancreatitis, liraglutide pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylureas, renal impairment, hypersensitivity, and acute gallbladder disease. The most common side effects reported in clinical trials for liraglutide injection include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.

Source:

FDA. (2024, December 23). FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. [Press release]. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes