The U.S. Food and Drug Administration (FDA) has approved the first generic version of liraglutide injection, a glucagon-like peptide-1 (GLP-1) receptor agonist, to improve glycemic control in adult and pediatric patients (10 years and older) with type 2 diabetes, as an adjunct to diet and exercise. The approval, granted to Hikma Pharmaceuticals, references Novo Nordisk’s Victoza and marks a significant step toward providing more affordable treatment options for a condition affecting over 38 million Americans.
Addressing Type 2 Diabetes with Generic Liraglutide
Type 2 diabetes is characterized by the body's ineffective use of insulin, leading to elevated blood sugar levels. Liraglutide, a GLP-1 receptor agonist, enhances blood sugar control by mimicking the effects of GLP-1 in the pancreas, an effect often diminished in individuals with type 2 diabetes. The generic version aims to provide the same therapeutic benefits as the brand-name drug at a reduced cost.
Iilun Murphy, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, stated, "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. 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."
Safety Information and Warnings
The prescribing information for generic liraglutide includes a Boxed Warning regarding the increased risk of thyroid C-cell tumors. The FDA advises against its use in patients with a personal or family history of medullary thyroid carcinoma or those with multiple endocrine neoplasia syndrome type 2. Additional warnings cover the risks of pancreatitis, hypoglycemia (especially when used with insulin or sulfonylureas), renal impairment, and gallbladder disease. Common side effects include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.
Efforts to Increase Access to Medications
The FDA is prioritizing the assessment of generic drug applications for drugs facing shortages, including liraglutide. This prioritization is part of the agency's Drug Competition Action Plan, designed to facilitate the development and approval of generic drugs, particularly complex products like GLP-1 receptor agonists. By clarifying regulatory expectations and offering guidance to manufacturers, the FDA aims to enhance patient access to essential treatments.
Clinical Evidence
The approval of liraglutide for pediatric patients aged 10 years and older was supported by data from a placebo-controlled trial within the LEAD program. The study involved 134 pediatric patients who received treatment for over 26 weeks. Results showed that approximately 64% of pediatric patients achieved an HbA1c of less than 7% with liraglutide, compared to just 37% with placebo, demonstrating the drug's efficacy in improving glycemic control in this population.
