The U.S. Food and Drug Administration (FDA) has approved the first generic version of a daily injectable GLP-1 medication for managing Type 2 diabetes, offering a more accessible treatment option for millions of Americans. The new generic, liraglutide, serves as an alternative to Victoza and shares similarities with semaglutide, the active ingredient in popular drugs like Ozempic.

Dr. Iilun Murphy, director of the FDA’s Office of Generic Drugs, highlighted the significance of this approval, emphasizing the FDA's ongoing commitment to advancing patient access to safe and effective generic drugs. "Generic drugs provide additional treatment options, which are generally more affordable for patients," she noted in a statement issued on December 23, 2024.

This announcement comes just weeks after the FDA approved the first generic version of Byetta (exenatide), another GLP-1 medication. Experts are optimistic that these approvals will alleviate shortages caused by the surging demand for injectable treatments for weight loss and diabetes, such as semaglutide (sold under Ozempic and Wegovy) and tirzepatide (marketed as Mounjaro and Zepbound).

Liraglutide is expected to play a crucial role in managing Type 2 diabetes, a chronic condition affecting over 38 million people in the United States. This condition arises when the body struggles to use insulin effectively, leading to elevated blood sugar levels. Traditionally diagnosed in adults, Type 2 diabetes is increasingly prevalent among children and teens.

The medication works by mimicking the effects of GLP-1, a hormone that aids in regulating blood sugar levels through the pancreas. However, the generic version of liraglutide carries a warning regarding the potential risk of thyroid C-cell tumors. It is contraindicated for individuals with a personal or family history of medullary thyroid carcinoma or those with multiple endocrine neoplasia syndrome type 2.

Clinical trials have reported common side effects of liraglutide, including nausea, diarrhea, vomiting, decreased appetite, dyspepsia, and constipation. Despite these risks, the availability of a generic GLP-1 option is anticipated to improve affordability and access for patients, marking a significant step in diabetes care.