AbbVie Receives CHMP Positive Opinion for Risankizumab (SKYRIZI™) for the Treatment of Moderate to Severe Plaque Psoriasis

NORTH CHICAGO, Ill., March 1, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for SKYRIZI™ (risankizumab), an investigational interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy.

AbbVie to Showcase Scientific Innovation and Research Advancements Across Dermatology Portfolio at 2019 AAD Annual Meeting

NORTH CHICAGO, Ill., Feb. 25, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present 19 abstracts during the 2019 American Academy of Dermatology (AAD) Annual Meeting, March 1-5, in Washington, D.C., including new data from the psoriasis pivotal trials for risankizumab, an investigational interleukin-23 (IL-23) inhibitor.

AbbVie Announces New Drug Application Accepted for Priority Review by U.S. FDA for Upadacitinib for Treatment of Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Feb. 19, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its New Drug Application (NDA) for upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis. Upadacitinib is an investigational once-daily oral JAK1-selective inhibitor being studied for multiple immune-mediated diseases.1-13 AbbVie anticipates a regulatory decision in Q3 2019.

AbbVie Submits New Drug Application to U.S. FDA and Marketing Authorization Application to EMA for Upadacitinib for Treatment of Adults with Moderate to Severe Rheumatoid Arthritis

NORTH CHICAGO, Ill., Dec. 20, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) for upadacitinib, an oral investigational JAK1-selective inhibitor, for the treatment of adult patients with moderate to severe rheumatoid arthritis.

AbbVie Announces HUMIRA® (adalimumab) Global Patent License with Momenta

NORTH CHICAGO, Ill., Nov. 6, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today patent license agreements with Momenta over its proposed biosimilar adalimumab product. Under the terms of the agreements, AbbVie will grant Momenta a non-exclusive license on specified dates to AbbVie's intellectual property relating to HUMIRA in the United States and in various other countries around the world in which AbbVie has intellectual property:

AbbVie's Upadacitinib Shows Significant Improvements in Physical Function, Pain and Quality of Life as a Monotherapy in Patients with Rheumatoid Arthritis in Phase 3 Patient-Reported Outcomes Data

NORTH CHICAGO, Ill., Oct. 23, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new patient-reported outcomes data from the ongoing Phase 3 SELECT-MONOTHERAPY trial evaluating upadacitinib (15 mg and 30 mg, once-daily), an investigational JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis who did not adequately respond to treatment with methotrexate.1 Improvements in physical function, health-related quality of life, pain and morning joint stiffness were reported after 14 weeks of treatment with upadacitinib monotherapy compared to patients continuing methotrexate.1 These results will be presented at the 2018 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting in Chicago.

Positive Phase 2b Data for AbbVie's Upadacitinib Show Significant Induction of Clinical Remission and Response in Patients with Ulcerative Colitis

NORTH CHICAGO, Ill., Oct. 22, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced positive results from U-ACHIEVE, an ongoing Phase 2b/3 dose-ranging study evaluating upadacitinib, an investigational JAK1-selective inhibitor, for induction and maintenance therapy in adult patients with moderately to severely active ulcerative colitis.1 After 8 weeks, upadacitinib (15/30/45 mg, once daily) met the primary endpoint of clinical remission (per Adapted Mayo Score) and all ranked secondary endpoints.1 These clinical data, in addition to patient-reported outcomes data from the study, are being presented at United European Gastroenterology (UEG) Week 2018 in Vienna, Austria. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

AbbVie Announces Global Resolution of HUMIRA® (adalimumab) Patent Disputes with Fresenius Kabi

NORTH CHICAGO, Ill., Oct. 18, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced today global resolution of all intellectual property-related litigation with Fresenius Kabi over its proposed biosimilar adalimumab product. Under the terms of the settlement agreements, AbbVie will grant to Fresenius Kabi a non-exclusive license to AbbVie's intellectual property relating to HUMIRA beginning on certain dates in certain countries where AbbVie has intellectual property:

AbbVie and Morphic Therapeutic Announce Collaboration Targeting Fibrotic Diseases

NORTH CHICAGO, Ill. and WALTHAM, Mass., Oct. 18, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, and Morphic Therapeutic, a biotechnology company developing oral integrin therapies, announced today that the companies have entered into a research and development collaboration designed to advance a number of Morphic's oral integrin therapeutics for fibrosis-related indications.

AbbVie Reinforces Leadership in Gastroenterology with New Data Showcasing Research Advancements Across Robust Portfolio at United European Gastroenterology (UEG) Week 2018

NORTH CHICAGO, Ill., Oct. 16, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced it will present new data across investigational medicines and HUMIRA® (adalimumab) at United European Gastroenterology (UEG) Week 2018 from October 20-24 in Vienna. These include four oral presentations of new data evaluating upadacitinib in both Crohn's disease and ulcerative colitis and risankizumab in Crohn's disease, as well as two poster presentations of HUMIRA data in Crohn's disease.