Novartis Presents Phase III Kidney Data at ERA 2026 for Vanrafia and Fabhalta

Late-breaking Phase III readouts for two approved therapies at a single congress rarely arrive without downstream consequences for manufacturing planning and regulatory timelines, and Novartis's slate at ERA 2026 (Glasgow, June 3–6) is no exception. The company will present data from 15 abstracts covering its kidney portfolio, with pivotal results for Vanrafia® (atrasentan) and Fabhalta® (iptacopan) headlining the programme alongside extended follow-up for investigational anti-APRIL therapy zigakibart in IgA nephropathy (IgAN).

For supply chain planners and CMOs tracking European demand signals, the APPLAUSE-IgAN final data for iptacopan and the 2.5-year eGFR results from the ALIGN trial for atrasentan represent the most consequential presentations. Both are designated late-breaker oral sessions on June 4, meaning the data sets are sufficiently novel to have bypassed standard abstract review, a marker of clinical weight that regulators and health technology assessment bodies in Europe will note. Iptacopan's APPLAUSE-IgAN results specifically address near-normal kidney function decline in prespecified IgAN subgroups, a finding with direct relevance to label expansion discussions under EMA frameworks.

The 124-week zigakibart dataset, presented June 5, extends the efficacy and safety picture for a therapy still in Phase I/II, but the duration of follow-up signals Novartis is building the evidentiary base required for a future ICH E6-compliant registration package. Separately, the APPRISE-C3G data platform abstract offers early real-world treatment patterns for iptacopan in complement 3 glomerulopathy, a condition where no approved therapy currently exists, a gap that positions iptacopan for a potential supplemental submission.

Also on the programme is the Phase III design disclosure for farabursen, an anti-miR-17 oligonucleotide targeting autosomal dominant polycystic kidney disease (ADPKD). Study design presentations at ERA typically precede site activation by six to twelve months, giving contract manufacturers and clinical supply teams a visible planning horizon for an oligonucleotide modality with distinct GMP requirements relative to small molecules.

The IgNITE multi-country real-world evidence integration abstract rounds out the regulatory-facing data, providing the kind of post-authorisation safety and utilisation evidence that 21 CFR Part 211-aligned quality systems and EMA pharmacovigilance obligations increasingly demand from commercial-stage products.

The degree to which ERA 2026 data accelerates European regulatory submissions for iptacopan's C3G indication and atrasentan's long-term IgAN label will become measurable against EMA's published validation timelines in the months following the congress.

Source: Novartis via GlobeNewswire, 26 May 2026.