FDA Approves Generic GLP-1 Medicine For Diabetes Treatment

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FDA Approves Generic GLP-1 Medicine For Diabetes Treatment










By Denise Maher, HealthDay Reporter

THURSDAY, Dec. 26, (2024 HealthDay News) -- The U.S. Food and Drug Administration (FDA) announced on Monday the approval of the first generic version of a daily injectable GLP-1 medicine for people with Type 2 diabetes.

Liraglutide, the generic for Victoza, is similar to semaglutide, the active ingredient in the popular weight-loss drug Ozempic.

The FDA supports the development of generic drugs, such as GLP-1s, by funding research and informing industry through guidance, Dr. Iilun Murphy, director of the FDA’s Office of Generic Drugs, said.

“Generic drugs provide additional treatment options which are generally more affordable for patients,” she said in a statement released Dec. 23, 2024.

“Today’s approval underscores the FDA’s continued commitment to advancing patient access to safe, effective and high-quality generic drug products.”

Last month, the agency approved the first generic version of this class of medications with green lighting, a generic version of Byetta (exenatide).

Experts hope the new approvals will help prevent shortages triggered by demand for injectable weight loss and type 2 diabetes drugs, including semaglutide (Ozempic, Wegovy) and tirzepatide (Mounjaro, Zepbound).

Liraglutide is expected to expand access for people managing type 2 diabetes, which affects more than 38 million Americans, according to federal health data.

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 is usually diagnosed in adults but has been increasingly diagnosed in children and teens.

Liraglutide improves blood sugar levels by creating effects similar to GLP-1 in the pancreas, often found at insufficient levels in people with type 2 diabetes.

The prescribing information for the generic version includes a warning 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 those who have an endocrine system condition called multiple endocrine neoplasia syndrome type 2.

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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