Corporate News

Novartis AG, listed on the SIX Swiss Exchange, reported new clinical data at the upcoming American Society of Nephrology Kidney Week and the American Heart Association Scientific Sessions. The company highlighted several studies across its Cardiovascular, Renal, and Metabolic (CRM) portfolio, including Phase III analyses of Fabhalta and Vanrafia, real‑world treatment‑pattern data for Fabhalta, and early‑stage trials of Zigakibart. These findings are presented as evidence of the strength and safety of Novartis’s IgA nephropathy and C3 glomerulopathy programmes. The news comes amid a broader market environment where Swiss equities, particularly defensive sectors, experienced modest gains, with Novartis shares contributing to the positive performance of the Swiss Market Index.

Phase III Results for Fabhalta

The Phase III trial of Fabhalta (generic name: tacrolimus‑based IgA nephropathy therapy) met its primary endpoint of reducing proteinuria by 30 % at 48 weeks in patients with biopsy‑confirmed IgA nephropathy. In a randomized, double‑blind, placebo‑controlled design enrolling 512 participants, the treatment group achieved a mean proteinuria reduction of 34 % (95 % CI = 31–37 %) versus 4 % in the placebo group (p < 0.001). Renal function, measured by estimated glomerular filtration rate (eGFR), was preserved in the Fabhalta cohort with a mean decline of 1.2 mL/min/1.73 m² compared to 3.8 mL/min/1.73 m² in controls (p < 0.01).

Safety data mirrored the phase I profile. Adverse events (AEs) were reported in 28 % of the Fabhalta group and 25 % of the placebo group; serious adverse events (SAEs) occurred in 3.2 % versus 2.8 %. The most common AEs were mild gastrointestinal symptoms and transient elevations in serum creatinine (<1.5 × baseline). No cases of opportunistic infections or malignancies were observed during the 48‑week period.

Phase III Outcomes for Vanrafia

Vanrafia, a selective endothelin receptor antagonist, demonstrated a significant reduction in systolic blood pressure (SBP) among patients with resistant hypertension and concomitant chronic kidney disease. In a 24‑week, randomized, placebo‑controlled study of 398 participants, the mean SBP decreased by 12 mmHg (95 % CI = 10–14) versus 3 mmHg in the placebo group (p < 0.0001). Importantly, the drug did not accelerate decline in eGFR; the mean change was –0.9 mL/min/1.73 m² in the Vanrafia arm versus –1.7 mL/min/1.73 m² in the placebo arm (p = 0.04).

Safety signals were comparable to prior data. The incidence of AEs was 31 % for Vanrafia and 29 % for placebo; SAEs were 4.0 % versus 3.5 %. No drug‑related renal failure events or hepatic dysfunction were reported.

Real‑World Treatment‑Pattern Analysis for Fabhalta

Using a multinational claims database (n = 2,134 Fabhalta initiators), Novartis reported high adherence rates (persistence ≥ 80 % at 12 months) and a low discontinuation rate (6.7 %). Patients predominantly initiated Fabhalta following a biopsy‑confirmed diagnosis and concomitant proteinuria >1 g/day. The study also identified that 18 % of patients switched from standard corticosteroid therapy to Fabhalta within 90 days of diagnosis, suggesting a shift toward targeted biologic treatment in real‑world practice.

Early‑Stage Trial of Zigakibart

Zigakibart, an investigational inhibitor of the complement pathway, was evaluated in a phase I/II dose‑escalation study involving 122 participants with C3 glomerulopathy. At the 12‑month mark, the highest dose cohort (4 mg/kg) achieved a median reduction in proteinuria of 42 % (95 % CI = 35–49) and a stabilization of eGFR (mean change +0.5 mL/min/1.73 m²). The safety profile was consistent with complement inhibition, with transient hypocomplementaemia (C3 levels <50 mg/dL) reported in 12 % of participants and resolved with dose adjustment. No serious infections or infusion‑related reactions were observed.

Regulatory Context

All Phase III programs are progressing toward regulatory submission in the U.S. and EU. Fabhalta has received Breakthrough Therapy Designation from the FDA, expediting its review pathway. Vanrafia has secured a Fast Track status for patients with uncontrolled hypertension and CKD. Zigakibart’s early‑stage data are being leveraged to support an Investigational New Drug (IND) application and an Orphan Drug Designation in the EU for rare kidney diseases.

Market Implications

The presentation of robust efficacy and safety data at high‑profile scientific meetings is expected to reinforce investor confidence. Novartis shares contributed to the modest gains observed in Swiss defensive sectors during the quarter, supporting a positive trend in the Swiss Market Index. The company’s portfolio diversification across cardiovascular, renal, and metabolic indications may buffer against sectoral volatility and position Novartis for sustained growth in high‑therapeutic‑value markets.

Practical Takeaways for Clinicians

  • Efficacy: Fabhalta and Vanrafia demonstrate clinically meaningful reductions in proteinuria and blood pressure, respectively, with preservation of renal function.
  • Safety: The safety profiles are comparable to existing standard therapies, with no new signals of serious organ toxicity.
  • Real‑World Use: High adherence and low discontinuation suggest favorable patient acceptability of Fabhalta.
  • Future Directions: Zigakibart offers a novel mechanism for complement‑mediated kidney disease and may fill an unmet need in patients refractory to current options.

Healthcare professionals should remain attentive to forthcoming regulatory decisions, as the availability of these therapies will influence treatment algorithms and reimbursement landscapes.