- For immediate release:
- June 17, 2019
The US Food and Drug Administration has approved the injection of Victoza (liraglutide) for the treatment of pediatric patients with type 2 diabetes from 10 years of age. Victoza is the first non-insulin drug approved for the treatment of type 2 diabetes in pediatric patients since metformin was approved for pediatric use in 2000. Victoza has been approved for the treatment of adult patients with type 2 diabetes since 2010.
"The FDA is encouraging drugs to be made available to as many patients as possible when there is evidence of safety and effectiveness," said Lisa Yanoff, Acting Director of Health and Safety. Metabolism and Endocrinology Products Division of the FDA's Center for Drug Evaluation. Research. "It has now been shown that Victoza improves glycemic control in pediatric patients with type 2 diabetes. The extended indication provides an additional treatment option at a time when a growing number of children are diagnosed with this disease. "
Type 2 diabetes is the most common form of diabetes. It occurs when the pancreas can not produce enough insulin to keep its blood sugar level at a normal level. Although type 2 diabetes mainly affects patients over the age of 45, the prevalence rate among younger patients has increased significantly over the past two decades. The diabetes report published by the US Centers for Disease Control and Prevention estimates that more than 5,000 new cases of type 2 diabetes are diagnosed each year among young Americans under the age of 20.
Victoza improves blood sugar levels by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas. GLP-1 is often found at inadequate levels in patients with type 2 diabetes. Like GLP-1, Victoza slows digestion, prevents the liver from producing too much glucose (a simple sugar), and helps the pancreas to produce more glucose. insulin when needed. As stated on the label, Victoza does not replace insulin and is not indicated in patients with type 1 diabetes or diabetic ketoacidosis, a disease associated with diabetes in which the body breaks down fat too quickly because insulin is insufficient or nonexistent. all. Victoza is also indicated to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease; However, its effect on major adverse cardiovascular events in pediatrics has not been studied and it is not indicated for this use in children.
The efficacy and safety of Victoza in reducing blood glucose levels in patients with type 2 diabetes have been studied in several placebo-controlled trials in adults and adults. a placebo-controlled trial in 134 pediatric patients aged 10 years and older for more than 26 weeks. Approximately 64% of patients in the pediatric study had a reduction in hemoglobin A1c (HbA1c) of less than 7% on Victoza, compared with only 37% of those who achieved these results with placebo. The HbA1c is a blood test performed routinely to assess the degree of diabetes control of a patient. A lower number indicates better control of the disease. These results were obtained whether the patient also took insulin at the same time or not. Adult patients taking Victoza with insulin or other drugs increasing the amount of insulin manufactured by the body (eg sulfonylurea) may present an increased risk of hypoglycemia (low blood sugar) Meanwhile, pediatric patients aged 10 years and older taking Victoza had a higher risk of hypoglycemia, whether or not they had taken any other diabetes treatment.
Victoza's prescription information includes a boxed warning to inform healthcare professionals and patients of the increased risk of thyroid C-cell tumor. For this reason, patients who have had or have family members who have previously had a medullary thyroid carcinoma (MTC) should not use Victoza, any more than patients with endocrine disorders called multiple endocrine neoplasia syndrome. type 2 (MEN 2). In addition, people who have ever had a severe hypersensitivity reaction to Victoza or any of the components of the product should not use Victoza. Victoza also contains warnings about pancreatitis, Victoza pen sharing, hypoglycemia when used in combination with certain medications known to cause hypoglycemia, including insulin and sulfonylurea, an insufficiency renal failure or kidney failure, hypersensitivity and acute gallbladder disease. The most common side effects are nausea, diarrhea, vomiting, loss of appetite, indigestion and constipation.
The FDA has granted this application priority review. Victoza's approval was granted to Novo Nordisk.
The FDA, an agency of the US Department of Health and Social Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.