FDA approves generic GLP-1 drug to treat type 2 diabetes

The U.S. Food and Drug Administration has approved the first generic version of Victoza (liraglutide injection), significantly improving access to diabetes treatment.

Glucagon-like peptide-1 (GLP-1) receptor agonists are designed to enhance glycemic control and complement diet and exercise therapy in adults and children 10 years and older with type 2 diabetes.

The agency said the approval marks a “pivotal moment” in ongoing efforts to address the shortage of GLP-1 therapeutics, which is a challenge for patients who need them. He said there is.

The FDA's decision to approve this generic version follows the recent approval of a generic drug that references another GLP-1 treatment, Byetta (exenatide). The agency is prioritizing the evaluation of generic drug applications for medicines in short supply to improve patient access to needed 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 that are generally more affordable for patients,” Murphy said.

Type 2 diabetes is a chronic disease that affects more than 38 million Americans and is characterized by an inability of the body to use insulin effectively, resulting in 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 increased risk of thyroid C-cell tumors and should not be used in patients with a history of medullary thyroid cancer or multiple endocrine tumor syndrome type 2. We recommend that you do not do so.

Additionally, the drug carries warnings about potential side effects such as pancreatitis, hypoglycemia, kidney damage, hypersensitivity, and acute gallbladder disease. Common side effects reported in clinical trials include nausea, diarrhea, vomiting, decreased appetite, indigestion, and constipation.

The FDA's approval is part of the Drug Competition Action Plan, which aims to overcome challenges and increase competition in generic drug development. The agency said it supports the development of complex generic medicines by providing guidance and clarifying regulatory expectations early in the development process.

Hikma Pharmaceuticals USA Inc. has received approval to manufacture generic liraglutide injection. Patients and healthcare providers are encouraged to contact the manufacturer for information regarding the availability of this drug.