Kerendia Type 1 Diabetes Approval: First New CKD Treatment in 30 Years

On 17 September 2026 the US Food and Drug Administration approved a supplemental new drug application for Kerendia (finerenone) in adults with chronic kidney disease associated with type 1 diabetes. The new Kerendia type 1 diabetes indication is to reduce urinary albumin-to-creatinine ratio (UACR), which FDA expects will reduce the risk of sustained eGFR decline and end-stage kidney disease.

It is the first new FDA-approved therapy for this population in more than 30 years, and the third US indication for Kerendia, after CKD associated with type 2 diabetes (July 2021) and heart failure with LVEF at or above 40% (July 2025). Bayer is now the only company with a non-steroidal mineralocorticoid receptor antagonist (nsMRA) indicated for CKD tied to either type of diabetes.

The decision is clinically meaningful and commercially useful, but it is not a conventional outcomes approval. FINE-ONE was a 242-patient, six-month albuminuria trial, and hard renal and cardiovascular event data in type 1 diabetes remain inferred from the type 2 diabetes program. That distinction will shape guideline language, US payer utilization management, and any future HTA submissions outside the United States.

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The Kerendia type 1 diabetes label

Kerendia’s US prescribing information now carries three adult indications:

The type 1 diabetes wording is narrower than the type 2 diabetes wording. There is no T1D claim for cardiovascular death, myocardial infarction, or heart-failure hospitalization. The dose for the new use is the established 10 mg or 20 mg once-daily tablet, with or without food, titrated against potassium and eGFR.

Unmet need

CKD develops in roughly 20-30% of US adults with type 1 diabetes and is a leading contributor to premature death in this population through kidney failure and cardiovascular events. Bayer cites an estimated two million people with type 1 diabetes in the United States, of whom about 30% will develop CKD over a lifetime.

Standard of care has been glycemic control, blood-pressure management, and renin-angiotensin system blockade, essentially the ACE-inhibitor evidence base from the 1990s. SGLT2 inhibitors have transformed T2D-CKD and heart-failure care but do not have a comparable T1D-CKD outcomes franchise. Bayer describes FINE-ONE as the first positive Phase III kidney study in T1D-CKD since that era.

Bayer’s global release states that, as of this decision, the United States is the only country where Kerendia is approved for CKD associated with type 1 diabetes. The T2D-CKD and HFpEF/HFmrEF indications are already broad (100-plus countries for T2D-CKD; US, EU, Japan, China and others for HF).

Clinical evidence

FINE-ONE design

FINE-ONE (NCT05901831) was a global, randomized, double-blind, placebo-controlled Phase III study in 242 adults with CKD associated with type 1 diabetes, run at more than 80 sites in nine countries. Patients received finerenone 10 or 20 mg once daily or placebo on top of standard care. The primary endpoint was relative change in UACR over six months, averaged over months 3 and 6. Results were presented as a featured high-impact trial at ASN Kidney Week 2025 and published in the New England Journal of Medicine in March 2026 (Heerspink et al., 2026;394(10):947-957).

Efficacy

A 30% UACR reduction is the threshold the American Diabetes Association associates with slower CKD progression. Benefit appeared by month 3 and was sustained to month 6. FINE-ONE was not powered for eGFR slope over years or for kidney-failure events.

Supportive T2D program

FDA also considered pooled FIDELIO-DKD and FIGARO-DKD data in T2D-CKD. Bayer has argued that more than 80% of finerenone’s kidney benefit in those trials was explained by UACR reduction, the pharmacologic rationale for accepting a T1D surrogate label. That mediation argument is the hinge of the entire T1D filing.

Implications for HEOR, pricing, and market access

United States

Coverage is the near-term question, not list price. Kerendia is already contracted in T2D-CKD and HF. Plans will decide whether the T1D use rides existing medical-exception or prior-authorization logic or gets its own criteria, including UACR threshold, background ACE/ARB, and potassium monitoring. Expect prior authorization to track the trial: type 1 diabetes, albuminuric CKD, background RAS blockade, and potassium and eGFR gates. A 30% UACR response at 3-6 months is a plausible continuation criterion if plans want an outcomes-style leash on a surrogate label.

Value dossiers should not copy-paste type 2 diabetes ICERs. The type 1 diabetes population is younger, has different competing mortality, and has no finerenone event trial. Modelers will need to translate UACR change into eGFR slope and ESKD using either FINE-ONE plus external natural history or a formal surrogate-to-outcome mapping from FIDELIO/FIGARO, with extensive sensitivity analysis. Quality measures and ADA Standards of Care language will move faster than CMS national policy, so watch the next ADA Standards update and KDIGO diabetes-in-CKD commentary.

Europe, UK, and other HTA markets

There is no T1D-CKD authorization outside the US. Any EU, UK, Canada, Australia, or Japan filing will face a different evidence bar. EMA and HTA bodies have accepted UACR and eGFR slope in some CKD settings, but several agencies still prefer event-driven or multi-year slope data when the population is distinct. NICE, HAS, G-BA, and TLV will ask whether type 2 diabetes outcomes can be transferred. If Bayer files on FINE-ONE alone, expect requests for indirect comparison versus optimized RAS blockade with or without SGLT2 use in selected T1D patients, and for lifetime ESKD/CV modeling with wide uncertainty.

Orphan or rarity arguments are weak: T1D-CKD is uncommon relative to T2D-CKD but not an orphan condition in major markets. On pricing, a T1D extension is unlikely to support a US-style price premium in Europe if the product is already reimbursed for T2D-CKD. The access task is indication listing and guideline pull-through, not a new price architecture.

What “first in 30 years” does and does not buy

The slogan is accurate as a regulatory fact and useful in medical education. It does not by itself establish cost-effectiveness, justify a new net price, or substitute for outcomes evidence in markets that treat type 1 diabetes as a separate decision problem. Access teams should use the 30-year gap to frame unmet need and then move quickly to the UACR-to-ESKD mapping and the hyperkalemia management burden.

What to watch

Bottom line

FDA gave Bayer a first-in-a-generation T1D-CKD claim on a clean, short, surrogate trial plus a mature type 2 diabetes outcomes story. Clinically, that closes a real gap. For value and access teams the work is just starting: document the UACR-to-kidney-failure link in type 1 diabetes, price and position the product as a franchise extension rather than a new molecule, and prepare a transferability package for every agency that will not automatically follow FDA.

The commercial prize in type 1 diabetes is modest next to T2D-CKD and the emerging non-diabetic CKD file. The strategic prize is ownership of the nsMRA class across diabetes types, and a template for how regulators treat cardiorenal surrogates in a smaller, historically neglected population.

Sources

• Bayer US press release, 17 September 2026
• Bayer global newsroom note, 17 September 2026
• Fierce Pharma, 17 September 2026
• MedPage Today, 17 September 2026
• Medscape, 17 September 2026
• Drugs.com approval history
• Heerspink HJL, et al. Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. 2026;394(10):947-957. doi:10.1056/NEJMoa2512854

Prepared 18 September 2026. Figures and label wording are taken from company and trade sources available on the day of writing and should be checked against the final FDA Prescribing Information when posted. This brief is analysis, not medical or legal advice.