The FDA has approved the first generic version of Victoza, which comes in the dosage form of 18 mg/3 mL of liraglutide injection. This medication belongs to a class of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists and is used to improve blood sugar control in patients with type 2 diabetes. It is prescribed alongside exercise and diet and can be taken by adults and children aged 10 and older.
This approval comes close to the recent FDA authorization of the first generic drug in this class Byetta (exenatide). Now, liraglutide injection as well as other drugs of the GLP-1 group is in shortage. To overcome this, the FDA has focused its generic drug approval efficiencies towards drugs that are in short supply to make the drugs more affordable to the patient.
The director of the Office of Generic Drugs at the FDA’s Center for Drug Evaluation and Research, Dr. Iilun Murphy, further pointed out that the challenges involved in developing complex generic drugs were cut across diverse therapeutic areas. He also pointed out that this effort required research funding and industry guidance. According to Murphy, generic drugs are typically those that show a significant effectiveness on patients, this aligns with the FDA’s objective to ensure pharmaceuticals are high-quality, safe, and efficacious.
Diabetes type 2 is a life-long condition in which the body cannot adequately utilize insulin hence the person’s blood sugar levels become too high. Typically emerging over the years, it was previously observed primarily in adults but is now increasingly appearing in children and teenagers. Liraglutide works in the same way by stimulating pancreatic secretion like GLP-1 hormone, usually at inadequate levels in type 2 diabetic patients.
This mechanism is crucial in managing normal blood sugar levels, as stated by the Centers for Disease Control and Prevention (CDC), approximately 38 million people in the United States have diabetes, with 90-95 % diagnosed with type 2 diabetes. Although liraglutide shows promising effects, it also shows a potential increased risk for thyroid C-cell tumors. Therefore, liraglutide is contraindicated in patients with a family history of medullary thyroid carcinoma as well as in patients having multiple endocrine neoplasia syndrome type-2. It should also be avoided by hypersensitive patients to liraglutide or other components of the drug. This is a warning to healthcare professionals while prescribing drugs to patients.
Other precautions include pancreatitis; hypoglycemia occurs when it is used concurrently with insulin or sulfonylurea; acute renal failure; allergic effects; and acute cholecystitis. The adverse effects reported in clinical studies include nausea, vomiting, diarrhea, loss of appetite, indigestion, and constipation.
Of the constructs, the FDA’s drug competition action plan highlights issues in generic development for competition strengthening and improved patients’ drug access. Because of the complex ingredients and formulation of the delivery system a potent drug like liraglutide is not easy to design. Hence the degrees of generic competition on these drugs remain very low. To address this there is transparency in the regulatory requirements starting with the development phase: an excellent support of the pre-abbreviated new drug application (ANDA) program among others. All these actions themselves are intended to help the role of the manufacturer in making cheaper drugs for some therapeutic choices and increase access for patients across the United States to required medications.
Now, with the approval of generic liraglutide injection, the fight against diabetes takes another step towards more efficient disease management. This approval has been granted to Hikma Pharmaceuticals USA Inc. If, as appears to be currently occurring, these generic medicines are becoming increasingly accepted, then this trend supports progress this development underpins initiatives within the emerging GLP-1 drug class. These concerns have not reduced the FDA’s focus and efforts for sustaining and enhancing the health standards of the US population through ways of enhancing the accessibility of medicines for patients with type 2 diabetes.
Reference: Rose McNulty. FDA Approves First Generic Daily GLP-1 Injection for Type 2 Diabetes. AJMC. Published December 23, 2024. Accessed December 26, 2024. FDA Approves First Generic Daily GLP-1 Injection for Type 2 Diabetes
