The U.S. Food and Drug Administration has approved the first generic version of Victoza (liraglutide injection), significantly improving access to diabetes treatment.
The glucagon-like peptide-1 (GLP-1) receptor agonist is designed to enhance glycemic control in adults and children 10 years and older with type 2 diabetes, complementing diet and exercise regimens.
The agency said the approval marks a “pivotal moment” in the ongoing efforts to address the shortage of GLP-1 medications, which has posed challenges for patients needing these treatments.
The FDA's decision to approve this generic version follows the recent approval of a generic referencing Byetta (exenatide), another GLP-1 medication. The agency has prioritized the assessment of generic drug applications for medications in shortage, trying to improve patient access to essential treatments.
Dr. Iilun Murphy, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, emphasized the importance of this latest development.
"Generic drugs provide additional treatment options which are generally more affordable for patients,” Murphy said. “
Type 2 diabetes, a chronic condition affecting over 38 million Americans, is characterized by the body's inability to use insulin effectively, leading to elevated blood sugar levels. Liraglutide works by mimicking the effects of GLP-1 in the pancreas, helping to regulate blood sugar levels in patients with insufficient GLP-1 production.
Potential side effects
The newly approved generic liraglutide injection includes a Boxed Warning about the increased risk of thyroid C-cell tumors, advising against its use in patients with a history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
Additionally, the drug carries warnings about potential side effects such as pancreatitis, hypoglycemia, renal impairment, hypersensitivity, and acute gallbladder disease. Common side effects reported in clinical trials include nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation.
The FDA's approval is part of its Drug Competition Action Plan, which aims to overcome challenges in developing generics and promote competition. The agency said it supports the development of complex generic drugs by providing guidance and clarifying regulatory expectations early in the development process.
Hikma Pharmaceuticals USA Inc. has been granted approval to manufacture the generic liraglutide injection. Patients and healthcare providers are encouraged to contact the manufacturer for information regarding the availability of this medication.