Bayer just scored another label expansion for its blockbuster-in-waiting, Kerendia. The heart and kidney med earned the first FDA nod in three decades for adults with chronic kidney disease associated with Type 1 diabetes.
Kerendia, also known as finerenone, was approved to reduce urinary albumin-to-creatine ratio (UACR), a key risk factor of worsening CKD, in patients with Type 1 diabetes associated CKD.
According to Bayer, the drug stands to benefit 30% of the estimated 2 million U.S. Type 1 diabetes patients who will develop CKD within their lifetime. UACR reduction with Kerendia is expected to reduce the risk of kidney disease progression in Type 1 diabetes-associated CKD, including declining kidney filtration rates and end-stage kidney disease.
The FDA decision was based on findings from Kerendia’s phase 3 Fine-one clinical trial in adult patients with CKD associated with Type 1 diabetes. The 242-subject trial showed that Kerendia reduced UACR by more than 25% after 6 months, with benefits observed as early as 3 months.
The data builds on Bayer’s clinical trial work in CKD associated with Type 2 diabetes, which demonstrated that UACR is an important marker of CKD progression. In Bayer’s Fidelio-DKD and Figaro-DKD trials, UACR reduction with Kerendia was associated with improved kidney outcomes including lower rates of kidney failure, sustained decrease in estimated glomerular filtration, and renal death.
The approval “provides an important new treatment option for a population that has continued to face substantial unmet need,” said Janet McGill, M.D., from Washington University School of Medicine in St. Louis and co-chair of the Fine-one study’s executive committee.
Kerendia is now the only non-steroidal mineralocorticoid receptor antagonist (MRA) indicated for adults with Type 1 or Type 2 diabetes-associated CKD. The label expansion marks the drug’s third indication since 2021 when it was first approved in Type 2 diabetes-associated CKD.
Then, last year, it picked up an approval for two types of heart failure: with preserved ejection fraction and mildly reduced ejection fraction. Bayer has more extensions up its sleeve after a phase 3 win in two of the most common forms of non-diabetic CKD earlier this spring.
Continued regulatory and commercial momentum for Kerendia is critical to Bayer’s overall growth strategy. The drug is key to offsetting losses as older medications like Xarelto and Eylea face increasing generic and biosimilar competition. In the second quarter of 2026, the two older products saw sales decline 42.4% and 32.8%, respectively, for Bayer.
While Bayer’s overall pharmaceutical sales were flat for Q2, Kerendia’s sales proved to be a bright spot, demonstrating a better-than-expected 83% increase year-over-year. The company is now predicting peak annual sales for the drug will climb to $3 billion.