Zydus Lifesciences Limited, a prominent global healthcare provider, has announced that it has received final approval from the United States Food and Drug Administration (USFDA) for its New Drug Application (NDA) for Zituvimetᵀᴹ XR (sitagliptin and metformin hydrochloride) extended-release tablets. This approval enables Zydus to market the medication in the U.S.

Zituvimetᵀᴹ XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. This approval is significant as Zydus now has all three NDAs of its Sitagliptin (base) and combination franchise approved through the 505(b)(2) route. Impressively, each of these NDAs achieved First-Cycle Approval (FCA), underscoring Zydus’s commitment to meeting rigorous regulatory standards efficiently.

Prescribing Zituvimetᵀᴹ XR (sitagliptin and metformin hydrochloride) extended-release tablets offer several potential benefits over other available drugs for managing type 2 diabetes mellitus:

• Combination Therapy Benefits through Dual Mechanism of Action: The combination of sitagliptin, a DPP-IV inhibitor, and metformin, a biguanide, provides a synergistic effect on glycemic control. Sitagliptin increases insulin production and decreases glucagon secretion, while metformin improves insulin sensitivity and reduces hepatic glucose production. This dual action can be more effective than either drug alone.
• Improved Glycemic Control with Effective HbA1c Reduction: Clinical studies have shown that combining sitagliptin and metformin can lead to greater reductions in HbA1c levels compared to monotherapy, helping patients achieve and maintain their target blood glucose levels more effectively.
• Extended-Release Formulation with Once-Daily Dosing: The extended-release formulation allows for once-daily dosing, which can improve patient adherence to the medication regimen by simplifying their treatment plan.
• Improved Safety and Tolerability for Lower Risk of Hypoglycemia: Sitagliptin, as a DPP-IV inhibitor, has a lower risk of causing hypoglycemia compared to some other classes of diabetes medications, such as sulfonylureas or insulin. This makes it a safer option for many patients.
• Weight Neutrality: Sitagliptin and metformin are generally weight-neutral, meaning they do not contribute to weight gain, which is an important consideration for many patients with type 2 diabetes who may be overweight or obese.
• Potential Cardiovascular and Renal Benefits: Emerging evidence suggests that DPP-IV inhibitors like sitagliptin may have favorable effects on cardiovascular and renal outcomes, which is critical given the increased risk of cardiovascular disease and kidney complications in patients with type 2 diabetes.
• Single Pill Combination for Convenience: Combining sitagliptin and metformin into a single pill can reduce the pill burden for patients, enhancing convenience and potentially improving medication adherence.
• Proven Efficacy and Safety Profile with Extensive Clinical Data: Both sitagliptin and metformin have been extensively studied, with robust clinical data supporting their efficacy and safety in managing type 2 diabetes. The combination product benefits from this extensive clinical experience.

The product will be manufactured at Zydus’s state-of-the-art formulation manufacturing facility located in Ahmedabad SEZ, India, ensuring high-quality production standards.

According to IQVIA (MAT May 2024), the U.S. market for DPP-IV inhibitors and their combinations is valued at $9.5 billion, reflecting a substantial market opportunity for Zituvimetᵀᴹ XR.

By offering a combination of sitagliptin and metformin in an extended-release formulation, Zituvimetᵀᴹ XR provides a comprehensive approach to managing type 2 diabetes, addressing multiple pathophysiological defects with the convenience of once-daily dosing, potentially improving patient outcomes and adherence.

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