FDA Approves Hikma’s Generic GLP-1 Agonist for Type 2 Diabetes

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The FDA has approved Hikma Pharmaceuticals’ 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 approval follows the recent authorization of a generic for Byetta, another GLP-1 receptor agonist, amid ongoing shortages of GLP-1 medications.¹

“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, MD, director, office of generic drugs, center for drug evaluation and research, FDA, in a press release. "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.”

Liraglutide mimics natural GLP-1 effects, helping to regulate blood sugar levels in patients with type 2 diabetes. The generic liraglutide includes a Boxed Warning highlighting the risk of thyroid C-cell tumors and is contraindicated for patients with a history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, as well as those with severe hypersensitivity to the drug. Other warnings cover risks such as pancreatitis, hypoglycemia, renal impairment, and gallbladder disease. Common adverse events include nausea, diarrhea, and vomiting.¹

According to the Centers for Disease Control and Prevention, over 38 million people in the United States are currently living with diabetes, with an estimated 90% to 95% of them having type 2 diabetes. Type 2 diabetes most often develops in people 45 years of age or older, but more and more children, teens, and young adults are also developing it.²

According to the World Health Organization, 14% of adults aged 18 years and older were living with diabetes in 2022, an increasefrom 7% in 1990. Additionally, 59% of adults over 30 years of age with diabetes were not taking medication for their diabetes in 2022, while treatment coverage was lowest in low- and middle-income countries. In 2021, it was the cause of 1.6 million deaths and 47% of all deaths due to diabetes occurred in patients under 70 years of age. Further, 530,000 kidney disease deaths were caused by diabetes, and high blood glucose causes around 11% of cardiovascular deaths.

Since the start of the 21^st century, mortality rates from diabetes have been increasing. However, the probability of dying from any one of the four main noncommunicable diseases (cardiovascular diseases, cancer, chronic respiratory diseases or diabetes) between 30 and 70 years of age decreased by 20% globally between 2000 and 2019.³

According to the FDA, the development of liraglutide can be more difficult due to its complex active ingredient, formulation or mode of delivery. As a result, many complex drugs lack generic competition. To address this issue and facilitate timely development and approval of needed medications, particularly complex products, the agency is currently working to clarify regulatory expectations for applicants early in the development process, including through guidance for industry and the pre-ANDA program.¹

References

1. FDA Approves First Generic of Once-Daily GLP-1 Injection to Lower Blood Sugar in Patients with Type 2 Diabetes. FDA. December 23, 2024. Accessed December 24, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-once-daily-glp-1-injection-lower-blood-sugar-patients-type-2-diabetes

2. Type 2 Diabetes. CDC. Accessed December 24, 2024. https://www.cdc.gov/diabetes/about/about-type-2-diabetes.html#:~:text=Overview,adults%20are%20also%20developing%20it.

3. Diabetes. WHO. Accessed December 24, 2024. https://www.who.int/news-room/fact-sheets/detail/diabetes