Today, the U.S. Food and Drug Administration approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter, a glucagon-like peptide-1 (GLP-1) receptor agonist indicated to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes as an adjunct to diet and exercise.
The FDA approved the first generic in this class of medications last month with the approval of a generic referencing Byetta (exenatide).
Liraglutide injection and certain other GLP-1 medications are currently in shortage. The FDA prioritizes assessment of generic drug applications for drugs in shortage to help improve patient access to these medications.
“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, M.D., director of the Office of Generic Drugs in the FDA’s Center for Drug Evaluation and Research. "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.”
Type 2 diabetes is a chronic condition that occurs when the body does not use insulin well and cannot keep blood sugar at normal levels. It develops over many years and is usually diagnosed in adults, but has been increasingly diagnosed in children, teens and young adults.
Liraglutide improves blood sugar levels by creating similar effects in the body as GLP-1 in the pancreas, which is often found in insufficient levels in type 2 diabetes patients. According to the Centers for Disease Control and Prevention, more than 38 million Americans have diabetes, and 90% to 95% of those individuals have type 2 diabetes.
The prescribing information for the generic liraglutide injection approved today includes a Boxed Warning to advise health care professionals and patients about the increased risk of thyroid C-cell tumors. For this reason, patients who have had, or have family members who have ever had medullary thyroid carcinoma should not use liraglutide, nor should patients who have an endocrine system condition called multiple endocrine neoplasia syndrome type 2. In addition, people who have a prior serious hypersensitivity reaction to liraglutide or any of the product components should not use liraglutide. Liraglutide also carries warnings about pancreatitis, liraglutide pen sharing, hypoglycemia when used in conjunction with certain other drugs known to cause hypoglycemia including insulin and sulfonylurea, renal impairment or kidney failure, hypersensitivity and acute gallbladder disease. The most common side effects reported in the clinical trials for liraglutide injection include nausea, diarrhea, vomiting, decreased appetite, dyspepsia and constipation.
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