FDA Approves Bayer's Kerendia for Type 1 Diabetes Kidney Disease
The approval marks the first new treatment in 30 years for chronic kidney disease associated with type 1 diabetes.
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.
More in Medicine & Biotech
Ebola Vaccine Trial Launches in DR Congo Outbreak Zone
Health workers in DR Congo have begun testing whether a vaccine designed for a different Ebola strain can protect against the current outbreak.
Beacon Gene Therapy for Rare Vision Loss Succeeds in Pivotal Trial
A pivotal trial of Beacon Therapeutics' gene therapy for X-linked retinitis pigmentosa improved visual acuity, clearing the path toward an FDA submission.
Alkermes orexin agonist shows early promise for ADHD
Early-stage data suggest Alkermes' orexin agonist could expand the drug class beyond sleep disorders into ADHD.
Telix to Buy ITM for $1.65B, Challenging Novartis in Radiopharma
The acquisition gives Telix a late-stage pipeline and supply network that could compete with Novartis' Lutathera.