Low Disease Activity Rates Rise in Ianalumab Groups Through Week 108

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 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.

Novartis presented long-term data from the NEPTUNUS extension study of ianalumab for Sjögren’s disease at ACR 2026. Continuous treatment showed sustained improvements in disease activity and salivary flow, with no new safety issues. Patients switching from placebo to ianalumab also saw benefits. The FDA decision is expected this year.