NMPA (China) approves Kerendia to treat chronic kidney disease associated with type 2 diabetes.- Bayer
Kerendia (10 mg or 20 mg), a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is indicated for the treatment of chronic kidney disease (CKD) (eGFR of greater than 25 to 75 mL/min/1.73 m2 with albuminuria) associated with type 2 diabetes (T2D) in adults, to reduce the risk of sustained eGFR decline and end-stage kidney disease.
The approval of Kerendia in China is based on the results of the pivotal Phase III study FIDELIO-DKD, presented at the American Society of Nephrology’s (ASN) Kidney Week 2020 and simultaneously published in the New England Journal of Medicine in October 2020 (previously cited).
Worldwide, T2D is the second leading cause of CKD and CKD-related deaths, with up to 40% of people with T2D developing CKD. China is the country with the largest number of adults with diabetes, with an estimated 140 million people living with diabetes and a further estimated 73 million people with undiagnosed diabetes. The prevalence of T2D has been increasing dramatically in China. As China also carries the highest burden of diabetes-related CKD worldwide, CKD associated with type 2 diabetes has become one of the most important health crises in China.
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