
FDA Approves First Generic Daily GLP-1 Injection for Type 2 Diabetes
The approval marks the second for a generic in this class of medications indicated to improve glycemic control in patients with type 2 diabetes as a complement to diet and exercise.
The FDA today
Liraglutide injection was initially approved for adults with type 2 diabetes in 2010, with an expanded indication in 2019 including children and adolescents aged 10 to 17 years.2 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.
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“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, MD, director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research, said in a statement.1 "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.”
Nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation were the most commonly reported adverse events in clinical trials for liraglutide injection, according to the release. 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.
References
1. FDA approves first generic of once-daily GLP-1 injection to lower blood sugar in patients with type 2 diabetes. News release. FDA. December 23, 2024. Accessed December 23, 2024.
2. FDA approves Victoza for the treatment of type 2 diabetes in children and adolescents aged 10-17 years. News release. Novo Nordisk. June 17, 2019. Accessed December 23, 2024.
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