AstraZeneca PLC (NYSE:AZN) reported the outcome of DERIVE, a Phase III trial that evaluated the safety and efficacy of FARXIGA® in people with Type 2 diabetes with moderate renal impairment. The results were exhibited at the Endocrine Society’s 100th Yearly Meeting and Expo.
FARXIGA is indicated as an adjunct to exercise and diet to enhance glycemic control in people with T2D mellitus. It is not indicated for the treatment of hypertension or CKD or for weight loss. Jim McDermott, PhD, the VP, US Medical Affairs, Diabetes, expressed that AstraZeneca is committed to assisting patients with comorbid and complex diseases like chronic kidney disease and T2D, which is shown through the breadth of their research and their innovative renal, metabolic and cardiovascular approach. The DERIVE trial will help them know more and offer additional report for FARXIGA in T2D.
DERIVE adds vital information to earlier dapagliflozin trials in people with moderate renal impairment and T2D diabetes. AstraZeneca is planning to present the data from DERIVE trial to the FDA to expand the breadth of data already enclosed within the prevailing FARXIGA Prescribing Information.
As per the Centers for Disease Control & Prevention, as many as 30.3 million residents in the U.S. have diabetes, and Type 2 Diabetes comprises for 90% to 95% of total diabetes cases. T2D is the major cause of CKD in the U.S., affecting more than 40% of patients, and keeping control of diabetes can help reduce patients risk of getting severe kidney disease.
AstraZeneca is pushing the limits of science with the objective of advancing life-changing drugs that intend to reduce the international burden and problems of diabetes. As a major therapy area for the firm, they are focusing their R&D initiatives on diverse patients and populations with significant co-morbidities, like obesity, non-alcoholic steatohepatitis, chronic kidney disease and cardiovascular disease.