The Food and Drug Administration (FDA) has on December 23, 2024, granted approval to Hikma Pharmaceuticals for its generic version of Novo Nordisk’s diabetes drug Victoza (liraglutide), which has been facing shortages across the United States. The decision introduces another option for patients amid rising concerns about accessibility and affordability of diabetes treatment.
This approved generic is particularly significant as it enters the market during the continuing deficit of the original drug. Since 2023, Victoza has been on the FDA's shortage list, compelling the agency to prioritize the review of generic drugs to ameliorate the lack of supply. Iilun Murphy, the director of the FDA's Office of Generic Drugs, emphasized the importance of generics, stating, "Generic drugs provide additional treatment options which are more affordable for patients." This statement resonates particularly well with consumers as they navigate costly chronic conditions like diabetes.
Approved for patients 10 years and older, Victoza serves as a pivotal treatment for type 2 diabetes, helping improve glycemic control when combined with dietary changes and exercise. The FDA's strategic focus on generics aims not only to alleviate shortages but also to stimulate healthy competition in the pharmaceutical market. This brings forth greater patient access to necessary medications.
Earlier this year, Teva Pharmaceuticals launched its authorized generic version of Victoza, marking increased competitiveness within the market. Unlike authorized generics, which are exact copies, Hikma’s branded generic may have minor differences but aims to provide broader access at potentially lower prices. Responding to the approval, Hikma Pharmaceuticals expressed satisfaction by saying, "We are pleased to have FDA approval to launch this important medicine and to provide broader access and greater affordability for the patients who rely on it." This sentiment reflects the company's commitment to addressing the pressing needs of patients struggling with diabetes.
Despite the new availability, demand for Victoza has been moderately decreasing. The waning interest arises from the expiration of the drug's patent along with the emergence of more effective treatment options, namely once-weekly medications like Novo's Ozempic and Eli Lilly’s Mounjaro. These alternatives, which also belong to the GLP-1 class, are gaining traction due to convenience and efficacy, steering many patients away from traditional treatments.
Beyond the benefits, it's important for healthcare providers and patients to understand the associated risks. The FDA-approved liraglutide injectable product carries warnings about serious side effects including the risk of thyroid C-cell tumors, pancreatitis, and acute gallbladder diseases. Notably, individuals with personal or family histories of certain thyroid cancers or multiple endocrine neoplasia syndrome type 2 should refrain from using the medication. Attention to dosage, potential hypersensitivity reactions, and compatible medications remains imperative for patient safety.
This FDA approval reflects the agency's continued commitment to allowing accessible treatment options for chronic conditions. It's also part of the broader strategy under the FDA's Drug Competition Action Plan, which aims to mitigate the challenges manufacturers face when developing complex generics such as GLP-1 medications. Such innovations are pivotal for enhancing competition and driving prices down, something desperately needed as millions live with diabetes. According to the Centers for Disease Control and Prevention, more than 38 million Americans suffer from this chronic condition, with approximately 90% to 95% diagnosed with type 2 diabetes.
The FDA’s proactive measures, supported by the necessary research and guidelines to facilitate generics, embody the agency's commitment to health equity and improved patient outcomes. With this very approval of Hikma's generic version of Victoza, patients now have more options than ever at their disposal, marking a significant step forward for diabetes care and patient autonomy.
