Chronic kidney disease (CKD) often moves silently and unpredictably. It is one of the most common complications stemming from diabetes, with up to 40% of all diabetics ultimately battling the complication.
With its new medicine Kerendia, Bayer aims to offer a treatment for a wide range of patients with kidney disease. At the American Diabetes Association's (ADA's) Scientific Sessions over the weekend, the German pharma giant touted several wins for the med.
In the first, investigators said the drug's effects in patients with CKD and Type 2 diabetes were independent of their HbA1c levels at the start of clinical trial program. The results came from an analysis of the drug's FIDELIO and FIGARO clinical trials.
While the investigators noted that higher HbA1c variability was associated with higher cardio and renal risks, they didn't find any difference in CV and kidney outcomes based on a patient's starting HbA1c levels, their HbA1c variability or their length of diabetes.
In the second presentation, investigators noted that Kerendia's cardio and kidney benefits weren't affected by a patient's use of a GLP-1 receptor agonist at the start of testing.
One way of interpreting this finding is that Kerendia works well with other therapies but also does a “very good job” in the absence of other meds, Bayer's vice president of cardiovascular medical affairs Sameer Bansilal said in an interview.
“As clinicians make their choices about these medications, I think the important takeaway for them is that this drug works, whether they are using it in conjunction with or in the absence of other diabetes medicine that have excellent impact on cardiovascular renal disease,” Bansilal added.
Thirdly at ADA, investigators presented exploratory data showing the med's promise in staving off diabetic retinopathy, which affects a large portion of people with diabetes and is among the leading causes of blindness worldwide. For that study, investigators looked at data from the FIDELIO and FIGARO studies and found that among 134 patients who received the drug, just five (3.7%) had experienced a vision-threatening event in one or more eye at 2 years. Among 110 patients who received placebo, that compared with seven (6.4%) who experienced a vision-threatening event at least one eye in the same time.
“This is obviously a signal that is of great interest from a medical therapy for such a disease that eventually ends up requiring surgical care,” Bansilal said.
Aside from the data presentations, the ADA updated its 2022 Standards of Medical Care in Diabetes to reflect the new data from Bayer.
Bayer believes that the drug will “come to be a mainstay” for cardiorenal therapy, Bayer's Bansilal added. Meanwhile, the company is continuing its research on the medicine, including in a heart failure study which it plans to report in the next year or two.
Kerendia received marketing authorization from the EU in February and won FDA approval last July. Last August, Bayer's pharma chief Stefan Oelrich predicted it could reach over 1 billion euros in peak sales.