Abbvie Inc Stock Price, News & Analysis

AbbVie announced positive results from two Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, evaluating risankizumab (150 mg) for adults with active psoriatic arthritis. At week 24, 57% and 51% of patients achieved the ACR20 response in KEEPsAKE-1 and KEEPsAKE-2, respectively, compared to 34% and 27% with placebo (p<0.001). Secondary endpoints also showed significant improvements in skin clearance and physical function. The safety profile was consistent with previous studies, with serious adverse events occurring in 2.5% and 4.0% of patients on risankizumab.

AbbVie has announced FDA approval for updated prescribing information for IMBRUVICA (ibrutinib) to include long-term efficacy and safety data for its combination use with rituximab in treating Waldenström's macroglobulinemia (WM). This update is based on the final analysis of the Phase 3 iNNOVATE study, demonstrating a 75% reduction in the risk of disease progression or death. IMBRUVICA remains the only FDA-approved treatment for WM, reinforcing AbbVie's commitment to blood cancer patients.

AbbVie (NYSE: ABBV) announced that the European Medicines Agency's CHMP has recommended the approval of RINVOQ™ (upadacitinib, 15 mg) for two additional rheumatic indications: active psoriatic arthritis and active ankylosing spondylitis. This recommendation is grounded in positive results from three key clinical studies demonstrating RINVOQ’s efficacy across multiple disease activity measures. If approved, RINVOQ will provide an oral, once-daily treatment option for these conditions in the EU, enhancing options for patients living with debilitating diseases.

AbbVie announced top-line results from the Phase 3b Heads Up study, demonstrating that upadacitinib (30 mg, once daily) achieved superior results to dupilumab (300 mg, every other week) in treating moderate to severe atopic dermatitis. At week 16, 71% of patients on upadacitinib reached EASI 75 compared to 61% on dupilumab (p=0.006). Upadacitinib also outperformed in itch reduction and skin clearance, with significant improvements seen as early as week 1. The safety profile was consistent with previous studies, though a treatment-related death was reported. Further results will be submitted for publication.

AbbVie announced positive results from the Phase 3 U-ACHIEVE study, demonstrating that upadacitinib (45 mg daily) achieved clinical remission in 26% of patients with moderate to severe ulcerative colitis at week 8, significantly outperforming the 5% in the placebo group (p<0.001). The study also reported enhanced endoscopic and histologic improvement rates of 36% and 30%, respectively, compared to placebo. Upadacitinib's safety profile remained consistent with prior studies, showing a low incidence of serious adverse events. Future results will be presented at medical meetings.

AbbVie announced promising results from an integrated analysis of two Phase 3 studies regarding the use of IMBRUVICA in treating high-risk chronic lymphocytic leukemia (CLL) patients. The long-term follow-up showed similar progression-free survival (PFS) and overall response rates (ORR) in high-risk and non-high-risk patients. With data spanning up to 8 years, the study demonstrated sustained efficacy of IMBRUVICA, significantly improving outcomes for patients with known poor prognostic markers. These findings underscore the importance of appropriate biomarker testing in optimizing treatment strategies for CLL patients.

AbbVie (NYSE: ABBV) presented new Phase 3 MURANO and CLL14 trial results at the 62nd ASH Annual Meeting, emphasizing the effectiveness of VENCLEXTA/VENCLYXTO in chronic lymphocytic leukemia (CLL). The MURANO trial showed a median progression-free survival (PFS) of 53.6 months with VenR versus 17.0 months with BR. The overall survival (OS) estimate was 82.1% for VenR compared to 62.2% for BR. In the CLL14 trial, uMRD levels indicated better PFS outcomes. These results highlight VENCLEXTA's potential to improve patient outcomes significantly.

AbbVie (NYSE: ABBV) presented new data from the Phase 2 CAPTIVATE trial at the 2020 ASH Annual Meeting, showcasing the efficacy of IMBRUVICA® (ibrutinib) combined with VENCLEXTA®/VENCLYXTO® (venetoclax) for treating chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). The results indicated a one-year disease-free survival (DFS) rate of 100% for patients receiving ibrutinib compared to 95.3% for placebo. This combination also demonstrated high rates of undetectable minimal residual disease (uMRD). The study's findings support a potential fixed-duration treatment option for CLL/SLL patients.

AbbVie and Frontier Medicines announced a strategic collaboration to discover and develop innovative small molecule therapeutics targeting challenging protein targets in oncology and immunology. AbbVie will provide an upfront payment of $55 million and cover R&D costs during pre-clinical development phases. The collaboration has the potential for milestone payments exceeding $1 billion and expanded target options. AbbVie aims to enhance its efforts in targeted protein degradation while Frontier retains rights to its internal programs.