The FDA has approved Bayer's Kerendia for adults with chronic kidney disease associated with type 1 diabetes. According to Fierce Pharma, this is the first regulatory clearance in 30 years for this specific patient population.
Kerendia is described as a heart and kidney medication, and the approval marks its third FDA indication. The new use reflects an expanding role for the drug beyond its previous approvals.
The milestone is significant because no new treatment has been cleared for this complication in three decades, giving patients with type 1 diabetes and chronic kidney disease a newly available option.