The U.S. Food and Drug Administration approved KERENDIA (finerenone) to reduce urinary albumin-to-creatinine ratio (UACR) in adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D). Announced Sept. 17 by Bayer following Priority Review of a supplemental NDA, this indication makes KERENDIA the first new therapeutic advance for this specific population in more than 30 years. The approval was supported by Phase III data from the FINE-ONE trial in CKD associated with T1D and by previously reported Phase III data from FIDELIO-DKD and FIGARO-DKD in CKD associated with type 2 diabetes (T2D).
FINE-ONE (NCT05901831) was a randomized, double-blind, placebo-controlled, global Phase III study that enrolled 242 adults with CKD associated with T1D. The study evaluated KERENDIA 10 mg or 20 mg once daily added to standard of care, with the primary objective of demonstrating superiority over placebo in reducing UACR averaged over Months 3 and 6.
KERENDIA significantly reduced UACR versus placebo over six months (p=0.0001). Reductions were observed by Month 3 and persisted through Month 6:
Safety and tolerability in FINE-ONE aligned with the established profile of KERENDIA in CKD associated with T2D. Overall rates of treatment-emergent adverse events were similar between groups (47.1% KERENDIA vs 49.2% placebo). Treatment-emergent serious adverse event rates were 11.8% with KERENDIA and 11.5% with placebo. Hyperkalemia occurred more frequently with KERENDIA (10.1%) than placebo (3.3%); treatment discontinuation due to hyperkalemia was reported in 1.7% of KERENDIA-treated patients versus 0% with placebo.
Detailed FINE-ONE results were presented at ASN Kidney Week 2025 and published in the New England Journal of Medicine.
Reducing UACR is considered a modifiable risk factor associated with CKD progression. Data from FIDELIO-DKD and FIGARO-DKD previously showed that reductions in UACR with KERENDIA were associated with improved kidney outcomes in adults with CKD and T2D. The FINE-ONE results, coupled with that prior evidence, supported bridging kidney outcomes from CKD associated with T2D to CKD associated with T1D for regulatory approval.
KERENDIA is a once-daily, oral, non-steroidal mineralocorticoid receptor antagonist indicated in multiple settings:
Physician commentary included in the source emphasized the unmet need in people with T1D and CKD and the clinical importance of having an additional therapeutic option that targets UACR.
Arrowhead Pharmaceuticals presented Phase 3 data from SHASTA-3 and SHASTA-4 for plozasiran, an investigational agent administered subcutaneously every three months, in adults with severe hypertriglyceridemia (sHTG). Presentations were made during a Hot Line Late-Breaking Science session at the ESC Congress 2026.
Both SHASTA-3 and SHASTA-4 met their primary and all prespecified secondary endpoints, demonstrating deep and durable reductions in triglycerides (TG) out to Month 12. Median TG reductions from baseline were 79% in one study and 81% in the other (p<0.0001 for both). More than 90% of plozasiran-treated patients achieved TG levels below the severe threshold of 500 mg/dL at Month 12, and more than half achieved TG below 150 mg/dL.
Across the two pivotal trials, 757 patients were randomized to receive plozasiran 25 mg subcutaneously every three months or placebo. In a prespecified pooled analysis of acute pancreatitis (AP) events from SHASTA-3 and SHASTA-4, plozasiran demonstrated a statistically significant reduction in AP:
Arrowhead described greater absolute benefit among patients at higher baseline risk for AP.
Pooled safety data from SHASTA-3 and SHASTA-4 indicated the following:
The most common TEAEs (≥5% in plozasiran-treated patients) included worsening glycemic control (14.3%) and diarrhea (5.6%), compared with 8.7% and 3.2%, respectively, for placebo. Despite a higher reporting of glycemic-control-related TEAEs, mean HbA1c changes were minimal to modest with no worsening of mean HbA1c over time.
Injection-site reactions were reported in 3.2% of plozasiran-treated patients and 2.0% of placebo-treated patients. There were no cases of anaphylaxis or systemic hypersensitivity. No clinically meaningful changes in platelet counts or meaningful elevations in ALT or AST relative to placebo were observed, and no cases met Hy’s law criteria. In a prespecified MRI-PDFF substudy, there was no statistically significant treatment-emergent increase in hepatic fat fraction (p=0.70).
The source reported that three fatal events occurred in plozasiran-treated patients but did not provide further detail about those events.
Arrowhead plans to use pooled data from SHASTA-3, SHASTA-4 and the MUIR-3 study to pursue marketing authorization for plozasiran in the broader sHTG population across multiple geographies. The company intends to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration before the end of 2026 and has purchased a U.S. FDA Priority Review Voucher to potentially accelerate review.
Arrowhead’s leadership characterized the data as supportive of APOC3 reduction in the liver as an important therapeutic approach in sHTG, highlighting the magnitude of triglyceride lowering, the reduction in acute pancreatitis events, quarterly dosing, and the overall safety and tolerability profile.