Zydus Lifesciences Secures USFDA Nod for Diabetes Drug

About Approval

Zydus Lifesciences Limited has achieved a significant milestone with the final approval of its New Drug Application (NDA) by the US Food and Drug Administration (USFDA). This paves the way for Zydus to market ZituvimetTM XR, an extended-release tablet combining sitagliptin and metformin hydrochloride, for the treatment of type 2 diabetes in the United States.

This marks a noteworthy achievement for Zydus, as all three of their NDAs for Sitagliptin (base) and combination products received approval through the 505(b)(2) route, signifying a streamlined process based on existing scientific data. Additionally, all three NDAs secured a desirable First-Cycle Approval (FCA), highlighting the efficiency of Zydus’ development efforts.

ZituvimetTM XR is designed to assist adults with type 2 diabetes in managing their blood sugar levels through a combination of lifestyle modifications and medication. The tablets will be manufactured at Zydus’ formulation facility in Ahmedabad SEZ, India.

This approval presents a lucrative opportunity for Zydus to tap into the vast US market for DPP-IV inhibitors and their combinations, which, according to IQVIA data, stands at a staggering USD 9.5 billion as of May 2024. Zydus’ entry into this market with a competitively priced and effective treatment option is sure to be met with significant interest from healthcare providers and patients alike. Zydus’ success with ZituvimetTM XR underscores the company’s commitment to developing innovative and accessible treatment options for patients worldwide. This USFDA approval is a testament to Zydus’ scientific expertise and its dedication to improving the lives of those living with type 2 diabetes.

Share Price Movement

Zydus Lifesciences Ltd. (ZYDUSLIFE) is currently trading downwards today, experiencing a decrease of Rs 32.30 or 2.73% from its previous closing price of Rs 1185.30. The stock’s price fluctuated throughout the day with a high of Rs 1168.75 and a low of Rs 1151.00. Looking at the bigger picture, Zydus Lifesciences’ share price has ranged between Rs 1203.20 (52-week high) and Rs 564.05 (52-week low). It’s important to note that the stock operates within a price band upper limit (currently Rs 1303.80) and a lower limit (currently Rs 1066.80) within which the price can fluctuate.

About Company

Zydus Wellness Ltd., established in 1988, is a leading consumer wellness company with an Indian heritage and a global footprint. The company focuses on holistic health and wellness, offering innovative, industry-leading products like Complan, Sugar Free, Glucon-D, Everyuth, Nycil, Sugarlite, and Nutralite. Headquartered in Ahmedabad and Mumbai, the company has manufacturing facilities in Aligarh, Sitarganj, Ahmedabad, and Sikkim, as well as 8 co-packing facilities in India, Oman, and Newzealand. Zydus Wellness combines healthcare, nutrition, and cosmeceutical products to provide quality wellness products, helping people pursue integrated well-being. The company’s business area includes the development, production, marketing, and distribution of health and wellness products.

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