AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) in Atopic Dermatitis

– In three pivotal Phase 3 studies, RINVOQ met co-primary and all secondary endpoints in adult and adolescent patients with moderate to severe atopic dermatitis[1-3]

– Also known as eczema, atopic dermatitis is a chronic, inflammatory skin disease affecting an estimated 10 percent of adults and 25 percent of adolescents [4-7]

– These submissions reinforce AbbVie’s commitment to bringing RINVOQ to more patients living with immune-mediated diseases

NORTH CHICAGO, IL, USA I October 19, 2020 I AbbVie (NYSE: ABBV) today announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for RINVOQ™ (upadacitinib) for the treatment of adults (15 mg and 30 mg, once daily) and adolescents (15 mg, once daily) with moderate to severe atopic dermatitis.

The atopic dermatitis indication applications to the FDA and EMA are supported by data from three pivotal Phase 3 studies. RINVOQ was studied without topical corticosteroids (TCS) in Measure Up 1 and Measure Up 2 and with TCS in AD Up.^1-3 In all three studies, RINVOQ demonstrated significant improvement in skin clearance and reduction in itch in adults and adolescents with moderate to severe atopic dermatitis compared to placebo.^1-3 RINVOQ met the co-primary endpoints including at least a 75 percent improvement in the Eczema Area Severity Index (EASI 75) from baseline and a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of 0/1 (clear or almost clear) at week 16.^1-3 Additionally, more patients treated with either dose of upadacitinib experienced a clinically meaningful reduction in itch, defined as improvement in Worst Pruritus Numerical Rating Scale (NRS)≥4.^1-3 The safety profile of RINVOQ was consistent across the three pivotal Phase 3 studies in atopic dermatitis.^1-3 No new safety risks of RINVOQ were observed in these studies compared to the safety profile observed in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis receiving RINVOQ.^1-3,8-11

“While there have been advancements in care, patients with moderate to severe atopic dermatitis continue to experience relentless itch and skin symptoms that can impact their everyday lives,” said Michael Severino, M.D., vice chairman and president, AbbVie. “These submissions are an important step forward in our commitment to providing an additional treatment option for those who struggle with this debilitating and often underappreciated disease.”

Atopic dermatitis is characterized by a cycle of itching and scratching that leads to cracked, scaly, oozing skin, which intensifies with worsening disease severity.^4,5,12 Between 20 to 46 percent of adults with atopic dermatitis have moderate to severe disease.¹³ The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease.^4-6

About RINVOQ™ (upadacitinib)

Discovered and developed by AbbVie scientists, RINVOQ is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.^1-3,14-22 In August 2019, RINVOQ received U.S. FDA approval for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, RINVOQ was approved by the European Commission for the treatment of adult patients with moderate to severe active rheumatoid arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. The approved dose for RINVOQ in rheumatoid arthritis is 15 mg. Phase 3 trials of RINVOQ in atopic dermatitis, psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.^14-22 Use of RINVOQ in atopic dermatitis is not approved and its safety and efficacy have not been established by regulatory authorities.

Please click here for the Full Prescribing Information and Medication Guide.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

References:

1. AbbVie Data on File. ABVRRTI70713.
2. AbbVie Data on File. ABVRRTI70838.
3. AbbVie Data on File. ABVRRTI70869.
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6. EFA. Atopic Eczema: Itching for Life Report. 2018. Available at: https://www.efanet.org/images/2018/EN_-_Itching_for_life_Quality_of_Life_and_costs_for_people_with_severe_atopic_eczema_in_Europe_.pdf. Accessed on October 13, 2020.
7. Eichenfield LF, 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(2):338-351. doi:10.1016/j.jaad.2013.10.010.
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11. Van der Heijde D, et al. Efficacy and Safety of Upadacitinib in a Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2/3 Clinical Study of Patients With Active Ankylosing Spondylitis. 2019 ACR/ARP; 2728.
12. University of Michigan Medicine. Atopic Dermatitis (Eczema). 2020. Available at: https://www.uofmhealth.org/health-library/hw216104#hw216107. Accessed on October 13, 2020.
13. Shrestha S, et al. Burden of Atopic Dermatitis in the United States: Analysis of Healthcare Claims Data in the Commercial, Medicare, and Medi-Cal Databases. Adv Ther. 2017;34(8):1989–2006.
14. Pipeline – Our Science | AbbVie. AbbVie. 2020. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on October 13, 2020.
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16. A Study to Compare Safety and Efficacy of Upadacitinib to Dupilumab in Adult Participants With Moderate to Severe Atopic Dermatitis (Heads Up). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03738397. Accessed on October 13, 2020.
17. 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. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02365649. Accessed on October 13, 2020.
18. A Study Comparing Upadacitinib (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). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03104400. Accessed on October 13, 2020.
19. 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. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT02819635. Accessed on October 13, 2020.
20. A Study Evaluating the Safety and Efficacy of Upadacitinib in Subjects With Active Ankylosing Spondylitis (SELECT Axis 1). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/study/NCT03178487. Accessed on October 13, 2020.
21. A Study to Evaluate the Safety and Efficacy of Upadacitinib in Participants With Giant Cell Arteritis (SELECT-GCA). ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03725202. Accessed on October 13, 2020.
22. A Study to Evaluate the Efficacy and Safety of Upadacitinib in Subjects With Takayasu Arteritis (SELECT-TAK). ClinicalTrials.gov. 2020. Available at https://clinicaltrials.gov/ct2/show/record/NCT04161898. Accessed on October 13, 2020.
23. RINVOQ™ (upadacitinib) [Package Insert]. North Chicago, Ill.: AbbVie Inc.

SOURCE: AbbVie