Biogen Inc.（BIIB）のニュースとイベントBIIBBiogen Inc.

Biogen Reports 52-Week Results of Skin Lupus Treatment Study

Biogen announced 52-week results from the Phase 2 part of the ongoing AMETHYST Phase 2/3 study of litifilimab in people living with cutaneous lupus erythematosus. The updated results, presented at the European Academy of Dermatology and Venereology 2026 Congress in Vienna, Austria, represent the longest dataset reported for litifilimab in CLE and further support its potential to achieve rapid and durable improvements in skin disease activity. In the study, participants treated with litifilimab in the double-blind, placebo-controlled period showed continued clinical improvements in skin disease activity through Week 52. Notably, participants who switched from placebo to litifilimab treatment at Week 24 experienced a rapid onset of treatment effect as early as four weeks. Litifilimab is being evaluated as a potential once-monthly, first-in-class treatment designed to reduce inflammation at its source by selectively targeting blood dendritic cell antigen 2 receptors on plasmacytoid dendritic cells, which play a central role early in the inflammatory process in CLE. In January 2026, litifilimab was granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration for the treatment of CLE. The Phase 2 portion of the ongoing Phase 2/3 AMETHYST study evaluated 93 adults with active skin symptoms for whom standard antimalarial medications were not effective or not tolerable. Over the course of a full year, the study tracked key measures of skin redness, scaling and disease activity to assess how well litifilimab helped participants achieve healthier skin. By Week 52, more than a quarter of participants who received litifilimab from the beginning of the study achieved the clinical endpoint of clear or almost clear skin, as measured by a Cutaneous Lupus Activity Investigators' Global Assessment Revised erythema score of 0 or 1, up from 19.0% at Week 24. Similar improvements were seen on the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity-70 measurement with 28.8% of participants receiving litifilimab from the beginning of the study achieving a 70% or greater reduction in CLASI A at Week 52, compared to 21.7% at Week 24. For participants who started the study on placebo and transitioned to litifilimab halfway through the study, the onset of benefit was rapid - as early as four weeks - when skin symptoms began to improve. By Week 52, approximately one in three of these crossover participants reported clear or almost clear skin. Over the course of the 52-week treatment period, litifilimab was generally well tolerated with a safety profile consistent with previously reported Phase 2 studies and no new safety signals identified. The majority of adverse events reported were mild or moderate in severity, and serious AEs occurred in 3.4% of participants during the extended treatment period. The most common AEs were nasopharyngitis, influenza and arthralgia.

Biogen Publishes Adolescent Subgroup Analysis Results from VALIANT Study

Biogen announced the publication of results from a prespecified adolescent subgroup analysis of the Phase 3 VALIANT study evaluating Empaveli in the Clinical Journal of the American Society of Nephrology, or CJASN. The dedicated subgroup analysis was first presented at the 2025 Annual Meeting of the European Society of Paediatric Nephrology, or ESPN. The analysis showed that a cohort of adolescents aged 12 to 17 years with C3 glomerulopathy, or C3G, or primary immune complex membranoproliferative glomerulonephritis treated with Empaveli achieved clinically meaningful reductions in proteinuria and stabilization of kidney function compared with placebo. The findings were consistent with results from the overall VALIANT population. Adolescents represented nearly half of the VALIANT study population, providing one of the largest randomized datasets in this age group for C3G and primary IC-MPGN. Among the adolescent cohort at Week 26, results included: EMPAVELI-treated adolescents achieved a 75% relative reduction in proteinuria versus placebo, with reductions observed as early as Week 4 and continuing through Week 26. In total, 71% of adolescents treated with EMPAVELI achieved at least a 50% reduction in proteinuria, compared with 4% receiving placebo. Overall, 57% of EMPAVELI-treated adolescents achieved both stable kidney function and at least a 50% reduction in proteinuria, compared with 4% receiving placebo. The publication follows the recent FDA-approved label expansion for EMPAVELI, making it the first and only therapy approved to reduce both proteinuria and the loss of kidney function in adults and adolescents aged 12 years and older. The label update was based on 52-week efficacy and safety data from the VALIANT study demonstrating substantial reductions in proteinuria and sustained preservation of kidney function, as measured by estimated glomerular filtration rate. EMPAVELI was well tolerated in adolescents, with a safety profile consistent with the overall VALIANT population.