NORTH CHICAGO, Ill., June 23, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of atogepant for the prophylaxis of migraine in adults who have four or more migraine days per month. If approved, AbbVie will be the only company to offer a once daily oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) treatment spanning both episodic and chronic migraine in the European Union (EU).
NORTH CHICAGO, Ill., June 22, 2023 /PRNewswire/ -- The board of directors of AbbVie Inc. (NYSE: ABBV) today declared a quarterly cash dividend of $1.48 per share.
NORTH CHICAGO, Ill., June 15, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive top-line results from COMMAND, its Phase 3 maintenance study, showing risankizumab (SKYRIZI®, 180 mg or 360 mg subcutaneous [SC]) achieved the primary endpoint of clinical remission (per Adapted Mayo Score) at week 52, as well as key secondary endpoints in adult patients with moderately to severely active ulcerative colitis.1 In the COMMAND maintenance study, patients from the Phase 2b/3 INSPIRE study who responded to induction treatment were re-randomized to receive risankizumab 180 mg SC, 360 mg SC or withdrawal from risankizumab treatment (risankizumab intravenous [IV] induction-only control group).1 Approximately 75% of patients previously failed at least one advanced therapy (biologics, JAK inhibitors and/or S1P receptor modulators) for ulcerative colitis.1
IRVINE, Calif., June 13, 2023 /PRNewswire/ -- Allergan Aesthetics, an AbbVie company (NYSE: ABBV) today announced the 20 incredible women entrepreneurs who will receive funding and mentorship through the BOTOX® Cosmetic and IFundWomen grant program. More than 6,500 women submitted applications and each one was carefully reviewed by a panel to select the winners. While the number of women-owned businesses in the country continues to grow, and is now estimated at 42 percent of all businesses in the U.S.,1 there is more work to be done, particularly in helping ideas translate into business opportunities addressing the "Confidence Gap."
NORTH CHICAGO, Ill., June 9, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced new findings demonstrating sustained long-term safety and efficacy of VENCLYXTO®/ VENCLEXTA® (venetoclax)-based combination therapies in patients with previously untreated CLL with co-existing conditions, as well as R/R CLL. The results are being presented during oral sessions at the European Hematology Association (EHA) Annual Congress in Frankfurt, Germany.
NORTH CHICAGO, Ill., June 6, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the Goldman Sachs 44th Annual Global Healthcare Conference on Wednesday, June 14, 2023. Robert A. Michael, vice chairman and president, Jeffrey R. Stewart, executive vice president, chief commercial officer and Roopal Thakkar, senior vice president, development and regulatory affairs and chief medical officer, will present at 10:00 a.m. Central time.
- At week 24, upadacitinib 30 mg given alone or as a combination therapy (ABBV-599 high dose [elsubrutinib 60 mg and upadacitinib 30 mg]) met the primary endpoint of systemic lupus erythematosus (SLE) Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day in patients with moderately to severely active SLE receiving standard lupus therapies1
- Upadacitinib maintained greater improvements in SLE disease activity at week 48 as measured by the British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA), SRI-4, Lupus Low Disease Activity State (LLDAS) and lupus flares compared with placebo2
- No new safety signals were observed beyond the known safety profile for upadacitinib. Types of adverse events reported with ABBV-599 high dose were similar to those reported for patients treated with upadacitinib alone2
- Study results are being presented as an oral presentation at the European Congress of Rheumatology, EULAR 2023
NORTH CHICAGO, Ill., May 25, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the New England Journal of Medicine (NEJM) published results from the pivotal Phase 3 clinical trials – U-EXCEL, U-EXCEED and U-ENDURE – evaluating upadacitinib (RINVOQ®) in adult patients with moderately to severely active Crohn's disease who have had an inadequate response, lost response or were intolerant to conventional therapy or a biologic agent.1-4
- Five-year results from SELECT-COMPARE evaluating the efficacy and safety of RINVOQ® (upadacitinib) and HUMIRA® (adalimumab), both in combination with methotrexate (MTX), are reported for adult patients with moderate to severely active rheumatoid arthritis (RA) who had an inadequate response to MTX1
NORTH CHICAGO, Ill., May 19, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLYTM (epcoritamab-bysp), as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B–cell lymphoma (HGBL), after two or more lines of systemic therapies. EPKINLY is approved under the FDA's Accelerated Approval program based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. EPKINLY is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration.
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