AbbVie Submits Biologics License Application to U.S. FDA for Investigational Treatment Risankizumab for Moderate to Severe Plaque Psoriasis

NORTH CHICAGO, Ill., April 25, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced that it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for treatment of patients with moderate to severe plaque psoriasis.

What Makes the Immune System Compromise Your Health?

Janus kinase (JAK) enzymes can be responsible for inappropriate activation of immune cells that play a critical role in autoimmune disorders.

Rheumatoid Arthritis: From Damage Control to Taking Control

Living with RA once meant documenting failure. Until one discovery led researchers down an uncharted path.

AbbVie Showcases New, Late-Breaking Investigational Data at 2018 American Academy of Dermatology (AAD) Annual Meeting

NORTH CHICAGO, Ill., Feb. 12, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced it will present new, late-breaking data across investigational medicines and HUMIRA® (adalimumab) at the 2018 American Academy of Dermatology (AAD) Annual Meeting (February 16-20, San Diego).

AbbVie's Upadacitinib Granted Breakthrough Therapy Designation from the U.S. Food and Drug Administration for Atopic Dermatitis

NORTH CHICAGO, Ill., Jan. 8, 2018 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation for the investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy. This Breakthrough Therapy Designation is supported by positive Phase 2b results previously announced in September 2017,11 and marks 13 Breakthrough Therapy Designations granted to AbbVie's investigational treatments since the company's inception in 2013. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

AbbVie to Present at the 36th Annual J.P. Morgan Healthcare Conference

NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the 36th Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2018. Richard A. Gonzalez, chairman and chief executive officer, will present at 10:30 a.m. Central time.

AbbVie to Present at the 36th Annual J.P. Morgan Healthcare Conference

NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV) will participate in the 36th Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2018. Richard A. Gonzalez, chairman and chief executive officer, will present at 10:30 a.m. Central time.

AbbVie's Upadacitinib Shows Positive Results as Monotherapy in Phase 3 Rheumatoid Arthritis Study, Meeting All Primary and Key Secondary Endpoints

NORTH CHICAGO, Ill., Dec. 20, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-MONOTHERAPY clinical trial. This ongoing study evaluated upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, as a monotherapy treatment in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond to treatment with methotrexate. Results showed that after 14 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study's primary endpoints of ACR20** and low disease activity (LDA)*** versus continuing prior stable methotrexate therapy.1 Both doses also achieved all ranked and all key secondary endpoints.1 Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

Risankizumab Meets All Co-Primary and Ranked Secondary Endpoints, Achieving Significantly Greater Efficacy Versus Standard Biologic Therapies in Three Pivotal Phase 3 Psoriasis Studies

NORTH CHICAGO, Ill., Oct. 26, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced positive top-line results from three pivotal Phase 3 clinical trials evaluating risankizumab, an investigational interleukin-23 (IL-23) inhibitor, compared to ustekinumab and adalimumab for the treatment of patients with moderate to severe chronic plaque psoriasis.1,2,3 Results showed that after 16 weeks of treatment, risankizumab (150 mg) met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) across all three studies versus placebo or adalimumab (based on trial design).1,2,3 Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.

AbbVie to Showcase Robust Immunology Portfolio with New and Late-Breaking Data at the 2017 ACR/ARHP Annual Meeting

NORTH CHICAGO, Ill., Oct. 24, 2017 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that data from 38 abstracts of HUMIRA® (adalimumab) and the company's portfolio of investigational immunology medicines will be presented at the 2017 American College of Rheumatology (ACR)/Association for Rheumatology Health Professionals (ARHP) Annual Meeting, November 3-8, in San Diego.