Novartis (NOT) Reports Sustained Remibrutinib Responses Through Week 52

Amgen presented phase 3 trial results for dazodalibep in Sjögren's disease, showing both dosing schedules reduced systemic disease activity more than placebo. Novartis awaits an FDA decision on rival ianalumab. Amgen's second phase 3 trial, OASIZ-303, is ongoing. No FDA-approved therapies exist for Sjögren's, an autoimmune disease.

Lupus patients are enrolling in experimental CAR-T trials despite recent deaths in trials by Novartis (3) and Bristol Myers Squibb (1). Doctors note the potential benefits outweigh risks for severe lupus cases. Novartis and Bristol Myers have paused trials but plan to resume. CAR-T is also being tested for other autoimmune diseases, with about 150 trials underway. Cabaletta Bio's therapy shows promise with a traditional manufacturing process.

Novartis reported 108-week data on ianalumab at ACR Convergence 2026, showing improved disease activity in Sjögren’s Syndrome patients. Continuous 300 mg monthly treatment group saw ESSDAI score improvement of -7.5 points. Low disease activity rates rose to 65.1% in continuous-treatment group and 60.9% in placebo-switch group. Novartis seeks FDA decision in 2026.

Novartis reported that its Sjögren’s disease drug candidate, ianalumab, showed sustained improvements in systemic disease activity through week 108 of treatment, according to the NEPTUNUS extension study. Patients taking a 300 mg monthly dose experienced a reduction in disease activity.

Novartis reported two-year data from its Phase 3 study of ianalumab, showing continued improvements in Sjögren's disease activity. Patients on the drug saw increased reductions in disease activity and low disease activity rates. Adverse event rates were comparable between groups. Novartis expects a U.S. FDA decision this year, with no approved treatments for Sjögren's outside China.

Novartis' experimental drug pelacarsen reduced lipoprotein(a) by 78% in a Phase 3 trial but failed to lower heart attack or stroke risk. The study involved 8,322 patients with elevated Lp(a) and prior cardiovascular events. Despite the significant reduction, the drug did not outperform a placebo. Novartis is halting development of the drug, while other companies continue testing Lp(a) treatments.