NORTH CHICAGO, Ill., Dec. 23, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) approved the update of the IMBRUVICA® (ibrutinib) Prescribing Information to include efficacy and safety data for the combination of IMBRUVICA with rituximab for the treatment of Waldenström's macroglobulinemia (WM), based on the final analysis of the Phase 3 iNNOVATE study. First approved in 2013, IMBRUVICA is currently available to patients with several types of blood cancer, as well as chronic graft-versus-host disease. It was approved as a monotherapy for WM in 2015 and as a combination therapy with rituximab in 2018 based on the iNNOVATE primary analysis.
NORTH CHICAGO, Ill., Dec. 11, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of RINVOQ™ (upadacitinib, 15 mg), an oral, once daily selective and reversible JAK inhibitor, for the expanded use in two additional rheumatic indications: the treatment of adult patients with active psoriatic arthritis and adult patients with active ankylosing spondylitis.5 The CHMP positive opinions are based on results from three pivotal clinical studies in which RINVOQ demonstrated efficacy across multiple measures of disease activity.1-3
NORTH CHICAGO, Ill., Dec. 10, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced top-line results from the Phase 3b Heads Up study showing that upadacitinib (30 mg, once daily) achieved superiority to dupilumab (300 mg, every other week) for the primary endpoint, the proportion of patients with at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) at week 16, in adults with moderate to severe atopic dermatitis.1 Of patients treated with upadacitinib, 71 percent achieved EASI 75 at week 16 compared to 61 percent of dupilumab-treated patients (p=0.006).1 Upadacitinib also showed superiority compared to dupilumab for all ranked secondary endpoints, including additional measures of skin clearance and itch reduction.1
NORTH CHICAGO, Ill., Dec. 9, 2020 /PRNewswire/ -- AbbVie, a research-based global biopharmaceutical company, is investing $50 million in a five-year program to support underserved Black communities across the United States. AbbVie will collaborate with six nonprofit partners, including Direct Relief, University of Chicago Medicine's Urban Health Initiative, National Urban League, Year Up, United Negro College Fund (UNCF) and Providence St. Mel School, to support health and education opportunity in underserved Black communities.
NORTH CHICAGO, Ill., Dec. 9, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive results from the Phase 3 induction study, U-ACHIEVE, which showed upadacitinib (45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 8, as well as all ranked secondary endpoints, in adult patients with moderate to severe ulcerative colitis.1 In the study, 26 percent of patients receiving upadacitinib achieved clinical remission compared to 5 percent of patients receiving placebo (p<0.001).1 U-ACHIEVE is the first of two Phase 3 induction studies to evaluate the safety and efficacy of upadacitinib in adults with moderate to severe ulcerative colitis.1
NORTH CHICAGO, Ill., Dec. 6, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), today announced results from a long-term integrated analysis of two Phase 3 clinical studies and additional pooled analysis evaluating the effect of IMBRUVICA (ibrutinib) based therapies for the first-line treatment of high-risk patients with chronic lymphocytic leukemia (CLL). The totality of data featured at the virtual 2020 American Society of Hematology (ASH) Annual Meeting continues to establish the treatment benefit of IMBRUVICA for CLL patients with or without high-risk disease.
NORTH CHICAGO, Ill., Dec. 5, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new, updated results from the Phase 3 MURANO and CLL14 clinical trials evaluating VENCLEXTA®/VENCLYXTO® (venetoclax) fixed duration treatment combinations at the virtual 62nd American Society of Hematology (ASH) Annual Meeting & Exposition (abstracts 125, 127, and 1310, respectively). These findings add to the growing body of data supporting the use of VENCLEXTA/VENCLYXTO in first-line or previously treated chronic lymphocytic leukemia (CLL) patients.
NORTH CHICAGO, Ill., Dec. 5, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new data from the Phase 2 CAPTIVATE (PCYC-1142) clinical trial evaluating IMBRUVICA® (ibrutinib) in combination with VENCLEXTA®/VENCLYXTO® (venetoclax) in previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) during an oral presentation session at the virtual 2020 American Society of Hematology (ASH) Annual Meeting (Abstract #123). The one-year disease-free survival (DFS) rate in patients randomized to placebo or ibrutinib after completing the combination regimen provides data to support a fixed-duration treatment that can offer CLL/SLL patients remission and time off treatment.
NORTH CHICAGO, Ill. and SOUTH SAN FRANCISCO, Calif., Dec. 2, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Frontier Medicines, Corp., a precision medicine company drugging challenging protein targets to develop breakthrough medicines that change the course of human diseases, today announced a global strategic collaboration to discover, develop and commercialize a pipeline of innovative small molecule therapeutics against high-interest, difficult-to-drug protein targets.
NORTH CHICAGO, Ill., Dec. 1, 2020 /PRNewswire/ -- AbbVie (NYSE: ABBV) will host a virtual immunology strategic update for investors on Monday, December 14, 2020 at 9:00 a.m. Central time. Richard A. Gonzalez, chairman of the board and chief executive officer, and members of the executive leadership team will present on AbbVie's immunology business and pipeline.
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