FDA Approves First Generic Daily GLP-1 Injection for Type 2 Diabetes: Daily Dose

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On December 23, 2024, we reported on on the US FDA approval of 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 (T2D).

The approval

Liraglutide injection is indicated as an adjunct to diet and exercise. The treatment was initially approved for adults with T2D in 2010, with an expanded indication in 2019 including children and adolescents aged 10 to 17 years. 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.

The most commonly reported adverse events in clinical trials for liraglutide injection were nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation. 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.

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