FDA approves first generic GLP-1 injection for type 2 diabetes in patients 10 years and up

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The US Food and Drug Administration (FDA) has approved the first once-daily generic glucagon-like peptide-1 (GLP-1) receptor agonist.

Announced on December 23, 2024, the approval marks the first generic approval referencing liraglutide 18 mg/3 ml (Victoza) and is indicated for improving glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.¹

“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,” said Iilun Murphy, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research.¹ "Generic drugs provide additional treatment options which are generally more affordable for patients.”

In recent years, the GLP-1 receptor agonist class has received historic levels of attention from the medical community and general public, alike. Although a considerable portion of this attention is attributable to revelations surrounding the weight management and cardiorenal benefits of the class, it had become a growing staple in type 2 diabetes management for nearly 2 decades, with exenatide (Byetta) boasting approval as an adjunct therapy in type 2 diabetes dating back to 2005.^2,3,4

The initial approval liraglutide came in the form of an indication as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes based on the landmark LEAD program. In 2017, the FDA approved a label expansion for the agent indicating it for reducing risk of 3 major adverse cardiovascular events in patients with type 2 diabetes.⁵

In 2019, an additional label expansion indicated the GLP-1 receptor agonist for treatment of pediatric patients 10 years or older with type 2 diabetes, marking the first approval for a non-insulin drug in type 2 diabetes among a pediatric population since the approval of metformin in 2000.⁶

The latter label expansion was based on a single placebo-controlled trial from within the LEAD program, which included 134 pediatric patients 10 years and older who received treatment for more than 26 weeks. This study concluded approximately 64% of pediatric patients achieved an HbA_1c of less than 7% with liraglutide compared to just 37% with placebo. 6

The generic approval of liraglutide injection by the FDA marks the second generic approval for a GLP-1 receptor agonist in 2024, with the FDA approving a generic referencing exenatide (Byetta) in November. The December 23, 2024 approval of a generic referencing liraglutide was awarded to Hikma Pharmaceuticals.¹

“Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products,” Murphy added.

In their release announcing the approval, the FDA pointed out prescribing information for liraglutide includes a Boxed Warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. The FDA also notes the most common side effects reported in the clinical trials for liraglutide injection include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.

References:

1. Office of the Commissioner. FDA approves first generic of once-daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes. U.S. Food and Drug Administration. 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. Campbell P. Semaglutide: The drug of today and a steppingstone to tomorrow. HCP Live. December 6, 2023. Accessed December 23, 2024. https://www.hcplive.com/view/semaglutide-drug-today-steppingstone-tomorrow.

3. Campbell P. A pillared approach: A suite of therapies for a spectrum of metabolic disease. HCP Live. December 5, 2024. Accessed December 23, 2024. https://www.hcplive.com/view/a-pillared-approach-a-suite-of-therapies-for-a-spectrum-of-disease.

4. Eli Lilly and Company. Amylin and Lilly announce FDA approval of Byetta(TM) (exenatide) injection. Eli Lilly and Company. April 29, 2005. Accessed December 23, 2024. https://investor.lilly.com/news-releases/news-release-details/amylin-and-lilly-announce-fda-approval-byettatm-exenatide.

5. Stewart J. Victoza (liraglutide) FDA approval history. Drugs.com. November 12, 2024. Accessed December 23, 2024. https://www.drugs.com/history/victoza.html.

6. Office of the Commissioner. FDA approves new treatment for pediatric patients with type 2 diabetes. U.S. Food and Drug Administration. June 17, 2019. Accessed December 23, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-pediatric-patients-type-2-diabetes.