FDA Approves Zydus Zituvimet for Type 2 Diabetes Treatment

Zydus Lifesciences Limited, known as “Zydus,” announced that the U.S. Food and Drug Administration (FDA) has granted approval for its New Drug Application (NDA) for Zituvimet, a medication designed to treat adults with Type 2 Diabetes Mellitus. Zituvimet is a combination of sitagliptin and metformin hydrochloride in tablet form, available in two dosages, 50 mg/500 mg and 50 mg/1000 mg.

Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, make up the active ingredients in Zituvimet. The medication is intended to be used alongside dietary and exercise adjustments to enhance glycemic control in adult patients with Type 2 diabetes.

The approval of Zituvimet is the culmination of extensive research, development, regulatory work, and manufacturing conducted by Zydus teams. Zituvimet has been rigorously tested for Nitrosamines and potential genotoxic impurities in line with the latest USFDA standards, ensuring compliance with current USFDA requirements regarding Nitrosamines in Sitagliptin-containing products.

Dr. Sharvil Patel, Managing Director of Zydus Lifesciences Limited, commented on the approval, stating, “The Zituvimet approval further builds on our previous approval of Zituvio (sitagliptin) and offers an increased accessibility and affordability to healthcare systems with regard to prescription drugs for Type II diabetes. The Zituvimet approval provides an affordable treatment option for healthcare systems to reduce the rate of growth in drug spending and improves the financial sustainability of the healthcare programs.”

According to IQVIA™ data from August 2023, the U.S. market for DPP-IV inhibitors and their combinations is valued at $10 billion.

About Zydus

Zydus is a global life sciences company dedicated to empowering individuals to lead healthier and more fulfilling lives. Their innovative approach encompasses the discovery, development, manufacturing, and marketing of a wide range of healthcare therapies. With 25,000 employees worldwide, Zydus is committed to making groundbreaking discoveries that transform lives. For more information, visit www.zyduslife.com.

Important Safety Information

Indications and Usage: Zituvimet is a combination of sitagliptin, a DPP-4 inhibitor, and metformin hydrochloride (HCl), a biguanide. It is indicated as an  adjunct to diet and exercise to enhance glycemic control in adults with Type 2 diabetes mellitus.

Limitations of Use: Zituvimet is not recommended for patients with Type 1 diabetes mellitus and has not been studied in patients with a history of pancreatitis.

Dosage and Administration: The recommended starting dose for patients not currently treated with metformin is 50 mg sitagliptin and 500 mg metformin HCl twice daily. For patients already taking metformin, the dosage should provide 50 mg sitagliptin twice daily and the existing metformin dose. Dosage adjustments are recommended for patients with an estimated glomerular filtration rate (eGFR) less than 45 mL/min/1.73 m2.

Dosage Forms and Strengths

Zituvimet is available in tablet form as follows:

•          Sitagliptin 50 mg and metformin HCl 500 mg tablets

•          Sitagliptin 50 mg and metformin HCl 1,000 mg tablets

Contraindications

Zituvimet is contraindicated in patients with severe renal impairment (eGFR below 30 mL/min/1.73 m2), acute or chronic metabolic acidosis (including diabetic ketoacidosis), and a history of a serious hypersensitivity reaction to sitagliptin, metformin, or any of the excipients in Zituvimet.

Warnings and Precautions

Zituvimet comes with certain warnings and precautions, including the risk of lactic acidosis, pancreatitis, heart failure, acute renal failure, vitamin B12 deficiency, hypoglycemia when combined with insulin or insulin secretagogues, hypersensitivity reactions, severe and disabling arthralgia, and bullous pemphigoid.

For a complete list of important safety information, consult the full Prescribing Information for Zituvimet.

To report any suspected adverse reactions, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or the FDA at 1-800-FDA-1088

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