Zydus Receives USFDA Approval for Zituvimet Med to Treat Adult Type-2 Diabetes

This medicine, a combination of sitagliptin and metformin hydrochloride, serves as an additional aid alongside diet and exercise to enhance glycemic control for adults with type-2 diabetes mellitus.

Pharmaceutical giant Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Zituvimet, a newly approved drug intended for treating type-2 diabetes mellitus in adults. 

This medicine, a combination of sitagliptin and metformin hydrochloride, serves as an additional aid alongside diet and exercise to enhance glycemic control for adults with type-2 diabetes mellitus.

The approval comes after extensive research and regulatory efforts by Zydus teams, including quality testing for Nitrosamines and potential genotoxic impurities in line with current FDA standards. Zituvimet meets the current FDA standards regarding Nitrosamines in Sitagliptin-containing products, ensuring its safety and efficacy.

Commenting on the development, Dr Sharvil Patel, managing director of Zydus Lifesciences Limited, said, "The Zituvimet approval enhances accessibility and affordability for prescription drugs for type II diabetes, offering an affordable treatment option. This will help reduce the growth in drug spending and enhance the financial sustainability of healthcare programs."

Data from research firm IQVIA MAT reveals that the US market for DPP-IV inhibitors and their combinations amounts to $10 billion.
Zydus Lifesciences Limited, previously known as Cadila Healthcare Limited, is a leading global healthcare provider in the Indian pharmaceutical landscape. 

Established in 1952 by Ramanbhai B Patel, the company has evolved under the Zydus group, displaying substantial financial growth from a modest INR 250 Cr in 1995 to over INR 17,000 Cr in FY-21.

In recent developments, Zydus Lifesciences and Lupin Limited have joined forces in a licensing and supply partnership to co-market Saroglitazar Mg. This collaboration is aimed at addressing Non-Alcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic SteatoHepatitis (NASH) in India.

The primary goal of this collaboration is to introduce an effective treatment for chronic liver diseases in the country.

Concurrently, in November, Zydus Lifesciences teamed up with Guardant Health, a US-based precision oncology leader, to introduce advanced biopsy tests in India and Nepal, catering to the need for improved cancer treatment options.

In October, Zydus also reported its acquisition of the UK-based LiqMeds Group for approximately INR 689 Cr. The company, through its wholly-owned subsidiary Zydus Pharmaceuticals UK Ltd, will also provide yearly earn-outs until 2026, contingent on achieving specific agreed milestones for the acquisition.