Zydus Lifesciences gets USFDA approval for type 2 diabetes drug

11 Jul 2022 , 11:42 AM

Empagliflozin and Metformin Hydrochloride tablets are used with proper diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. They are also used to lower the risk of cardiovascular death in patients with type 2 diabetes mellitus and established cardiovascular disease. The drug will be manufactured at the groups formulation facility at SEZ, Ahmedabad, India. As per IQVIA MAT May 2022 data, the tablets had annual sales of $281 million in the United States. Currently, the group has 316 approvals and has so far filed over 420 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04, the company stated. Separately, Zydus Lifesciences said that it has launched the molecule Sitagliptin in India under the brand names Sitaglyn and Siglyn to address Type 2 diabetes in India. Sitaglyn and Siglyn will add on to a comprehensive solution for the management of Type 2 diabetes by providing access to quality care to the patients at an affordable cost, approximately 60% lesser than the originator. Sitaglyn and Siglyn offers an oral solution to the patients. Sitagliptin is the gold standard in the Dipeptidyl peptidase 4 inhibitor (DPP4i) category with over 62% market share in the global market. The drug provides an achievement of Hemoglobin A1C (HbA1c) goals with proven safety profile. With more than 77 million active patients, India is the diabetes capital of the world after China. As per the data, 67% of these patients are unable to achieve their HbA1c goal. Indias oral anti-diabetic market is worth Rs 12,500 crore, of which DPP4i class of anti-diabetics has a share of more than Rs 4,000 crore. Zydus has several leading brands to address diabetes including Lipaglyn, Dapaglyn, Vinglyn and Tenglyn. With the launch of these brands, Zydus said that it is expanding its diabetes management offerings for patients and strengthening its presence in the anti-diabetic market. Dr. Sharvil Patel, managing director of Zydus Lifesciences said, ?The addition of Sitaglyn and Siglyn to our diabetes portfolio will give patients access to a world-class oral therapy to help people manage their diabetes better by making it more affordable. Our high quality product will expand the reach of the molecule to patients in India, supported by our wide distribution network. The drug will help patients achieve their HbA1C goals reducing the disease burden and providing better patient-care and quality of life.? Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Zydus Lifesciences reported 41.5% fall in consolidated net profit to Rs 397.4 crore despite a 5.3% increase in total income from operations to Rs 3,863.8 crore in Q4 FY22 over Q4 FY21. The scrip rose 0.49% to currently trade at Rs 367.60 on the BSE. Powered by Capital Market – Live News