AstraZeneca Plc. announced that the US FDA has accepted and granted Priority Review to its supplemental Biologics License Application (sBLA) for Ultomiris (ravulizumab) for adults with immunoglobulin A nephropathy (IgAN). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date during the fourth quarter of 2026. This regulatory milestone follows the Phase 3 I CAN trial, which met a prespecified interim endpoint demonstrating a statistically significant and clinically meaningful reduction in proteinuria compared with placebo at week 34.

Ultomiris Reduces Proteinuria

The interim analysis revealed that patients treated with Ultomiris achieved a 46.6% reduction in 24-hour urine protein creatinine ratio (UPCR) from baseline. In contrast, the placebo group recorded a 5.6% reduction. The placebo-adjusted treatment effect was 43.4%, reaching statistical significance (p<0.0001).

Early and Sustained Response

The reduction in proteinuria emerged as early as week 10 and remained consistent through week 34. At week 10, Ultomiris-treated patients showed a 36.7% reduction in proteinuria, compared with 8.5% for those on placebo. The benefit was observed across multiple patient subgroups, including individuals with varying demographic characteristics and disease severity.

Jonathan Barratt, Mayer Professor of Renal Medicine at the University of Leicester and an investigator in the I CAN trial, noted that terminal complement activation plays a significant role in inflammation and kidney function decline in IgAN. He stated that the interim findings suggest targeting this pathway with Ultomiris may provide a disease-modifying approach.

Safety Profile and Regulatory Impact

Gianluca Pirozzi, Senior Vice President and Head of Development, Regulatory and Safety at Alexion, AstraZeneca Rare Disease, emphasized the early and meaningful reduction in proteinuria, particularly among patients at higher risk of disease progression. He added that the findings support the role of terminal complement inhibition in IgAN and will help advance regulatory filings in key markets. The safety profile was consistent with the known profile of Ultomiris, with no new safety concerns identified.

AstraZeneca Plc is advancing its oral GLP-1 receptor agonist, elecoglipron, into an extensive Phase 3 development program after the drug delivered significant weight-loss and diabetes-control results in two Phase 2b studies. The findings, presented at the 2026 Scientific Sessions of the American Diabetes Association and published in The Lancet, support the company's efforts to expand its cardiometabolic, renal, and weight-management portfolio. Elecoglipron is an investigational oral, once-daily, small-molecule GLP-1 receptor agonist that mimics the natural GLP-1 hormone.

VISTA Trial Demonstrates Significant Weight Reduction

The VISTA study enrolled 310 adults with obesity or overweight and at least one related comorbidity. Participants receiving elecoglipron 75 mg achieved an average body-weight reduction of 10.5% at 26 weeks, compared with 0.6% for placebo. Weight loss continued through week 36, reaching 11.8% in the treatment group versus 0.3% with placebo. The trial also met its co-primary endpoint measuring the proportion of participants achieving at least 5% weight loss, with up to 88.8% of patients on elecoglipron reaching that benchmark. Researchers also reported improvements in exploratory cardiometabolic measures, including reductions in blood pressure and C-reactive protein, a marker of systemic inflammation.

SOLSTICE Trial Shows HbA1c And Weight Benefits

In the SOLSTICE trial, which enrolled 404 adults with Type 2 diabetes, elecoglipron achieved an average HbA1c reduction of 1.9% at 26 weeks, compared with 0.2% for placebo. Most patients receiving the treatment reached guideline-recommended glycemic targets. By week 26, 90% recorded HbA1c levels below 7%, while 85% achieved HbA1c levels of 6.5% or lower. The treatment also produced an average body-weight reduction of 7.7%, compared with 1.7% for placebo.

Safety Profile And Next Steps

Across both studies, adverse events were largely gastrointestinal and generally mild to moderate in severity. The most frequently reported events included nausea, constipation, diarrhea, and vomiting. Discontinuations due to adverse events were uncommon, and investigators reported no liver safety signals. Hypoglycemia was infrequent in the diabetes study, with no serious cases linked to treatment. The Phase 3 development plan includes the EMBOLD trials in obesity and overweight populations, as well as the ELUMINATE studies evaluating elecoglipron alone and in combination with dapagliflozin for Type 2 diabetes. Additional studies will assess long-term cardiovascular and kidney outcomes.