News & Events zu AbbVie Inc. (ABBV)ABBVAbbVie Inc.

AbbVie Submits Biologics License Application for Etentamig to FDA

AbbVie announced the submission of a Biologics License Application to the U.S. FDA for etentamig, a second-generation BCMA x CD3 bispecific antibody T-cell engager administered intravenously for the treatment of adults with relapsed or refractory multiple myeloma.

AbbVie’s Skyrizi Approved by FDA for Crohn's Disease

AbbVie announced the U.S. Food and Drug Administration has approved a subcutaneous induction regimen for Skyrizi for adults with moderately to severely active Crohn's disease. "Patients now have the option to start Skyrizi treatment at home, with induction doses delivered by an on-body injector induction pack and then continue using an OBI once every eight weeks throughout the course of maintenance treatment," the company stated. "People living with Crohn's disease need treatments that can deliver meaningful disease control from the start. With the approval of subcutaneous induction, we are building on the strong efficacy of Skyrizi while giving patients and physicians greater flexibility in how treatment is initiated. This is one more example of how AbbVie continues to advance treatment to better meet the needs of people living with Crohn's disease," said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie.

AbbVie Reports Positive Phase 3 Results for Lutikizumab

AbbVie announced positive topline results from the Phase 3 INTREPID study evaluating the safety and efficacy of lutikizumab, an investigational dual-variable-domain interleukin 1alpha/1beta antagonist, in adults and adolescents with moderate to severe hidradenitis suppurativa. The study met its primary endpoint and 8 ranked secondary endpoints. In the INTREPID study, patients treated with lutikizumab achieved significantly higher response rates for the primary endpoint of HiSCR75 at Week 16 compared with placebo. HiSCR75 is defined as at least a 75% reduction from baseline in the total abscess and inflammatory nodule count, with no increase in abscess count and no increase in draining fistula count relative to baseline. INTREPID is the first phase 3 study including adults and adolescents with HS to demonstrate statistically significant HiSCR75 response rates at Week 16 as the primary endpoint. Lutikizumab also demonstrated statistically significant improvements across key ranked secondary endpoints, including rapid reductions in HS-related pain and significantly fewer HS flares, compared to placebo. At Week 8, 26.2% of patients treated with lutikizumab achieved NRS3, defined as at least a 3-point reduction from baseline in HS-related skin pain on the Numeric Rating Scale, compared with 15.0% of patients receiving placebo. Improvements in NRS3 were reported as early as Week 1. In addition, at Week 8, 36.0% of patients receiving lutikizumab achieved NRS30, defined as at least a 30% reduction and at least a 2-unit reduction from baseline in HS-related skin pain, compared with 22.8% of patients receiving placebo. Lutikizumab also significantly reduced the occurrence of HS flares during the first 16 weeks compared with placebo. Additional improvements were observed in quality-of-life measures, including changes from baseline in the dermatology life quality index and hidradenitis suppurativa impact assessment. Key potential disease drivers, including IL-17A and IL-17F levels were also reduced over the double-blind 16-week treatment period. These findings reinforce the potential for lutikizumab to address the burden of disease for people living with moderate to severe HS.