Bayer’s Kerendia Wins FDA Approval for Type 1 Diabetes-Related Kidney Disease, First in 30 Years

Bayer’s heart and kidney drug Kerendia has received U.S. Food and Drug Administration (FDA) approval for adults with chronic kidney disease (CKD) associated with type 1 diabetes. It is the first approval for this indication in 30 years.

According to Fierce Pharma on the 18th local time, the FDA approved Kerendia (ingredient: finerenone) to reduce the urinary albumin-to-creatinine ratio (UACR) in patients with CKD associated with type 1 diabetes. UACR is a key risk factor for worsening CKD.

Bayer estimates that 30% of the approximately 2 million people with type 1 diabetes in the United States will progress to CKD during their lifetimes and said they could be eligible for Kerendia. Reducing UACR is expected to lower the risk of disease progression, including declines in kidney filtration rate and end-stage kidney disease.

The approval was based on results from the phase 3 FINE-ONE clinical trial involving 242 adults with CKD associated with type 1 diabetes. Kerendia reduced UACR by at least 25% after 6 months of treatment, with effects observed as early as 3 months.

Janet McGill, MD, a professor at Washington University School of Medicine and co-chair of the FINE-ONE study executive committee, said the approval “provides an important new treatment option for a patient population that has continued to face substantial unmet needs.”

Kerendia is now the only nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated for adults with CKD associated with either type 1 or type 2 diabetes. This is its third indication since it was first approved for CKD associated with type 2 diabetes in 2021.

Bayer added approvals last year for 2 types of heart failure: heart failure with preserved ejection fraction and mildly reduced ejection fraction. This spring, the company also reported positive phase 3 results in the 2 most common forms of nondiabetic CKD, opening the possibility of further expanding the drug’s indications.

Kerendia’s growth is important to Bayer’s overall strategy. As existing products such as Xarelto and Eylea face generic and biosimilar competition, sales of the 2 products fell 42.4% and 32.8%, respectively, in the second quarter of this year.

Bayer’s total pharmaceutical sales were flat in the second quarter, but Kerendia sales rose 83% year over year, exceeding expectations. Bayer forecasts that Kerendia’s peak annual sales could reach $3 billion.