Zydus gets USFDA nod for Zituvimet for type-2 diabetes mellitus treatment
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Drugmaker Zydus Lifesciences Limited on Monday announced that it has received the final approval from the United States Food and Drug Administration (USFDA) for its New Drug Application (NDA) for Zituvimet to treat adult patients with type-2 diabetes mellitus. Zituvimet is composed of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus.
The company said in a press release that Zituvimet has been given the nod based on the research and regulatory work performed by Zydus teams and has undergone quality testing for Nitrosamines and potential genotoxic impurities according to current FDA standards. The product is compliant with current FDA standards of Nitrosamines in Sitagliptin-containing products, the company added.
Dr Sharvil Patel, managing director of Zydus Lifesciences Limited, said, "The Zituvimet approval further builds on our previous approval of Zituvimet (Sitagliptin) and offers 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 data released by research firm IQVIA MAT, the US market for DPP-IV inhibitors and their combinations is $ 10 billion.
On Oct 31, Zydus said it had acquired UK-based LiqMeds Group for around Rs 689 crore. The drugmaker, through its wholly-owned subsidiary Zydus Pharmaceuticals UK Ltd, will also pay yearly earn-outs until 2026, depending on the achievement of certain agreed milestones towards the acquisition.
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