FDA Approves First Once-Daily Generic of Victoza for Type 2 Diabetes

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The FDA has approved the first generic of Victoza (liraglutide injection) for adults and pediatric patients older than 10 with type 2 diabetes, according to a recent news release. This 18 mg/3 mL injection, glucagon-like peptide-1 (GLP-1), is approved for use in combination with diet and exercise. This approval was granted to Hikma Pharmaceuticals USA Inc.

The first generic GLP-1, Byetta (exenatide), was approved by the FDA last month.

More than 38 million Americans have diabetes, with type 2 being the most common, accounting for 90% to 95% of all diabetes cases, according to the Centers for Disease Control and Prevention.

Type 2 diabetes is a chronic condition that develops over many years. Patients are unable to regulate their blood sugar levels because their bodies do not use insulin well. Type 2 diabetes is usually diagnosed in adults, but in recent years it has become more common in children and adolescents. Although the exact cause is unclear, risk factors like obesity, family history and smoking tobacco increase likelihood of developing the disease.

Liraglutide mimics GLP-1, a naturally occurring hormone in the pancreas that regulates blood sugar levels by releasing insulin.

There has been a shortage of GLP-1 medications since 2023 due to high demand driven by the popularity of drugs like Ozempic, which is approved to treat type 2 diabetes but is used off-label as a weight loss medication.

“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, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research said in the news release. "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.”

The most common side effects of liraglutide injection include nausea, diarrhea and vomiting. Prescribing information also includes a warning for the potential formation of thyroid C-cell tumors. Patients who have a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.