- 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.
– The co-primary endpoints of endoscopic response (visible reduction of intestinal lining damage) and clinical remission were achieved by significantly more patients treated with RINVOQ (upadacitinib) at week 12 and week 52 versus placebo1
– Clinical response was achieved by significantly more patients treated with RINVOQ (upadacitinib) versus placebo as early as week 2 in induction studies1
– This indication marks the seventh FDA approval for RINVOQ across gastroenterology, rheumatology and dermatology1
IRVINE, Calif., May 15, 2023 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of SKINVIVE™ by JUVÉDERM® to improve skin smoothness of the cheeks in adults over the age of 21.1 SKINVIVE™ by JUVÉDERM® is the first and only hyaluronic acid (HA) intradermal microdroplet injection for skin smoothness available in the U.S. with results lasting through six months with optimal treatment.1
- Oral presentations highlight efficacy and safety outcomes from the upadacitinib (RINVOQ®) clinical trial program in adults with moderately to severely active Crohn's disease, and investigational use of linaclotide (LINZESS®) in treating functional constipation in pediatric patients aged 6 to 17 years
NORTH CHICAGO, Ill., May 2, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the Bank of America Securities Healthcare Conference on Tuesday, May 9, 2023. Robert A. Michael, vice chairman and president, Scott Reents, executive vice president, chief financial officer, 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.
NORTH CHICAGO, Ill., April 27, 2023 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2023.
NORTH CHICAGO, Ill., April 21, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced positive data from its Phase 3 ELEVATE study, evaluating atogepant for the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications. The results of the study demonstrated adult patients in the atogepant 60 mg once daily (QD) arm experienced a decrease of 4.20 days in their mean monthly migraine days (MMDs) across the 12-week treatment period, which was statistically significantly greater than the 1.85 day reduction observed in the placebo arm (p<0.0001). The data will be presented during the Emerging Science session on Tuesday, April 25, at the 2023 American Academy of Neurology (AAN) Annual Meeting taking place in Boston, Massachusetts.
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