MSD / Pfizer diabetes cooperation, three new drug applications are expected to be approved

Source: Merck and Pfizer announced recently that the FDA of the United States has accepted the review of three new drug applications (NDA) containing ertugliflozin Ertugliflozin is a sodium glucose cotransporter 2 (SGLT2) inhibitor under development, which can effectively improve blood glucose control in adult patients with type 2 diabetes mellitus: one is the single drug therapy of ertugliflozin; one is the fixed dose combination of ertugliflozin and januvia (sitagliptin); the other is the fixed dose combination of ertugliflozin and metformin The date of action of the FDA prescription drug user fee Act (PDUFA) for the above three NDA applications is December 2017 Diabetes is one of the most common chronic diseases in the world In short, diabetes means too much sugar in the blood circulation Blood glucose (glucose) is an important and necessary energy source for the body Our body has a set of fine system to regulate the amount of sugar in the blood circulation, so that the blood glucose value is usually maintained at a certain level The system centers on a hormone called insulin Insulin accelerates the conversion of blood sugar and is used as a source of energy or as a reserve Type 2 diabetes usually results from insulin tolerance If the body is not sensitive to insulin, and does not have enough insulin to overcome this insensitivity, it will suffer from type 2 diabetes Type 2 diabetes is the most common type of diabetes in the world, accounting for 90-95% of all diabetes ▲ the hypoglycemic mechanism of SGLT2 inhibitors (photo source: Tulane University) At present, the new hypoglycemic drug sodium glucose cotransporter 2 (SGLT2) inhibitors have attracted much attention in the field of diabetes treatment These drugs mainly act on sodium glucose transporter 2 in proximal tubules of kidney By inhibiting these transporters, the filtered glucose can be prevented from reabsorption in the kidney, so as to effectively control the blood glucose level Moreover, the treatment of SGLT2 inhibition does not depend on insulin ▲ SGLT2 inhibitors prevent glucose reabsorption (photo source: SIRONA Biochem) In addition, the European Drug Administration (EMA) has also confirmed the review of three marketing authorization applications (MAA) for single drug treatment and two fixed dose combination products This listing application to FDA and EMA is supported by research data of vertis clinical development project, including vertis mono, vertis clinical and vertis sita2 These results were first reported at the 2016 medical conference The full vertis clinical development program conducted up to nine phase 3 trials in approximately 12600 adults with type 2 diabetes "FDA and EMA's acceptance of the three applications represents an important milestone in our cooperation with Pfizer in the process of ertugliflozin, reflecting the commitment of MSD to promote innovative treatment options for patients with type 2 diabetes globally," said Sam, vice president of clinical research, diabetes and endocrinology at Merck "If approved, we believe that for many patients, ertugliflozin will be an important treatment option," Engel said It also means that we have a strong DPP-4 inhibitor januvia as a new member of the basic type 2 diabetes combination " Dr James rusnak, chief development officer of Pfizer's global product development, cardiovascular and metabolic diseases, also commented: "because type 2 diabetes is a progressive disease, patients may need a variety of treatment options to help them manage their condition That's why we are proud of the comprehensive vertis clinical development program, and we look forward to working closely with FDA and EMA to bring these three more treatment options to adult type 2 diabetic patients " Reference: [1] Merck & Co (MRK) and PFE (PFE) announcement FDA and EMA filling acceptances of three marketing applications for ertugliflozin containing medicines for adults with type 2 diabetes