NVS News & Events

The New England Journal of Medicine reports: "Sounding Board announces a new FDA policy that the default requirement for FDA approvals will be one robust pivotal trial plus confirmatory evidence, rather than two trials." Publicly traded companies in the space include AstraZeneca (AZN), Bristol Myers (BMY), Eli Lilly (LLY), GSK (GSK), Johnson & Johnson (JNJ), Merck (MRK), Novartis (NVS), Pfizer (PFE), Roche (RHHBY) and Sanofi (SNY).

Novartis announced topline results from its Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, ClndU. The primary endpoint was met for the three most prevalent types of CIndU: symptomatic dermographism, cold urticaria and cholinergic urticaria, achieving significantly higher complete response rates versus placebo at Week 121. These data represent an important advance in the treatment of CIndU, demonstrating the potential of remibrutinib to be the first targeted therapy for CIndU and address a major unmet need. "The positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief for people living with CIndU and build on its recent FDA approval in chronic spontaneous urticaria," said Angelika Jahreis, Global Head, Immunology Development, Novartis. "Today's findings reinforce that remibrutinib could be the first targeted therapy to improve spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for people living with these conditions."

Novartis announced final results from the Phase III ALIGN study supporting a slowing decline in kidney function in adults with IgA nephropathy who were treated with Vanrafia. Vanrafia showed a difference of 2.39 ml/min/1.73m2 in estimated glomerular filtration rate change from baseline vs. placebo at Week 136, 4 weeks after the end of study treatment. Clinically meaningful results were observed with Vanrafia compared to placebo in eGFR change from baseline at the end of study treatment at Week 132, and in the prespecified exploratory group of patients additionally receiving sodium-glucose co-transporter-2 inhibitors. At the end of treatment at Week 132, the eGFR change from baseline compared to placebo was 2.59 ml/min/1.73 m2. Vanrafia received accelerated approval in U.S. and China for reduction of proteinuria in adults with IgAN in 2025; Novartis plans to submit for traditional approval in 2026.