Bayer scores FDA nod for chronic kidney disease med

July 12, 2021

The FDA has given a new Bayer drug the green light for treating chronic kidney disease in patients with type 2 diabetes.

The company announced recently that the agency approved Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) for adults with type 2 diabetes to reduce the progression of chronic kidney disease and the risk of associated cardiovascular issues such as hospitalization for heart failure or cardiovascular death.

The drug will face competition from two SGLT2 inhibitors from J&J and AstraZeneca that are already on the market. But Bayer, which is under pressure as two of its top sellers — Eylea and Xarelto — near their patent cliff, is banking on the 40% of type 2 diabetes patients who develop chronic kidney disease to fuel growth for Kerendia. Bayer said that the class of medication is also a differentiating factor.

“KERENDIA is the first and only nonsteroidal mineralocorticoid receptor antagonist proven to significantly slow chronic kidney disease progression and reduce cardiovascular risk in people with chronic kidney disease associated with type 2 diabetes,” Amit Sharma, M.D, Vice President of Cardiovascular and Renal, Bayer U.S. Medical Affairs, said in a statement. “We are excited to bring this new kidney-focused treatment to people living with this condition.” 

Bayer plans to roll out the medication by the end of the month.