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

- Breakthrough Therapy Designation is granted to investigational treatments for serious diseases with preliminary clinical evidence that the treatment may demonstrate substantial improvement over existing therapies 1
- Upadacitinib, an investigational oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in atopic dermatitis and across multiple immune-mediated diseases2-9
- Phase 3 clinical program for upadacitinib in atopic dermatitis, the most common type of eczema, is planned to begin in the first half of 201810

NORTH CHICAGO, IL, USA I January 8, 2018 I 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.

Atopic dermatitis, a chronic inflammatory skin disease, is characterized by skin erosion, oozing and crusting, redness, intense itching (pruritus) and dry skin.12 Symptoms can appear as a rash on the skin, or the skin may become thickened and leathery.13

The FDA's Breakthrough Therapy Designation program is intended to expedite the development and review of medicines with preliminary clinical evidence that indicate that the investigational treatment may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.1

"Our history, scientific expertise and leadership in immunology drive our focus to develop new treatment approaches that address urgent and unmet needs," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Current treatment options for people living with atopic dermatitis are limited, and addressing these patient needs is important to us. We look forward to advancing upadacitinib into Phase 3 studies for atopic dermatitis soon."

In the U.S. alone, atopic dermatitis affects an estimated 28 million people of all ages, and can have a significant impact on the physical and psychosocial health of patients.10,14-16

AbbVie will present additional data from the Phase 2b trial at upcoming scientific congresses. Additional information on the clinical trials for upadacitinib is available at www.clinicaltrials.gov.

About Upadacitinib
Discovered and developed by AbbVie, upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of immune-mediated disorders.2,3 Phase 3 trials of upadacitinib in rheumatoid arthritis, psoriatic arthritis and Crohn's disease are ongoing and it is also being investigated to treat ulcerative colitis, ankylosing spondylitis and atopic dermatitis.4-9

About AbbVie
AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.

References
1 U.S. Food and Drug Administration. Fact Sheet: Breakthrough Therapies. https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm. Accessed January 3, 2018.
2 Voss, J, et al; Pharmacodynamics Of a Novel Jak1 Selective Inhibitor In Rat Arthritis and Anemia Models and In Healthy Human Subjects. [abstract]. Arthritis Rheum 2013;65 Suppl 10 :2374. DOI: 10.1002/art.2013.65.issue-s10
3 Pipeline – Our Science | AbbVie. AbbVie. 2017. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed January 3, 2018.
4 A Study Comparing ABT494 to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone (SELECT-NEXT) - Full Text View - ClinicalTrials.gov. Clinicaltrialsgov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02675426. Accessed on January 3, 2018.
5 A Study Comparing ABT-494 to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (SELECT - PsA 1). Clinicaltrialsgov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400?term=ABT-494&phase=2&rank=10. Accessed on January 3, 2018.
6 A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of ABT-494 for the Induction of Symptomatic and Endoscopic Remission in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Immunomodulators or Anti-TNF Therapy - Full Text View - ClinicalTrials.gov. Clinicaltrialsgov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on January 3, 2018.
7 A Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis. Clinicaltrialsgov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on January 3, 2018.
8 A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). 2018. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487?term=ABT-494&cond=ankylosing+spondylitis&rank=1. Accessed on January 3, 2018.
9 A Study to Evaluate ABT-494 in Adult Subjects With Moderate to Severe Atopic Dermatitis. Clinicaltrialsgov. 2018. Available at: https://clinicaltrials.gov/ct2/show/NCT02925117. Accessed on January 3, 2018.
10 American Academy of Dermatology. "Eczema." Available at: https://www.aad.org/media/stats/conditions/eczema. Accessed on January 3, 2018.
11 AbbVie Data on File. Upadacitinib AD Phase 2b Press Release 05SEPT2017.
12 Simon Francis Thomsen. Atopic Dermatitis: Natural History, Diagnosis, and Treatment. ISRN Allergy.doi:10.1155/2014/354250.
13 Williams HC. Clinical practice. Atopic dermatitis. N Engl J Med. 2005;352(22):2314-24.
14 Eichenfield LF, Tom WL, Chamlin SL, et al. Guidelines of care for the management of atopic dermatitis: section 1. Diagnosis and assessment of atopic dermatitis. J Am Acad Dermatol. 2014;70:338-51.
15 Thyssen JP, Hamann CR, et al. Atopic dermatitis is associated with anxiety, depression, and suicidal ideation, but not with psychiatric hospitalization or suicide. Allergy. 2018 Jan;73(1):214-220. doi: 10.1111/all.13231. Epub 2017 Aug 2.
16 Gupta MA, Gupta AK. Psychiatric and psychological co-morbidity in patients with dermatologic disorders. Am J Clin Dermatol. 2003;4(12):833-42.

SOURCE: AbbVie

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