AbbVie Submits Regulatory Applications for SKYRIZI® (risankizumab) in Psoriatic Arthritis to FDA and EMA

NORTH CHICAGO, Ill., April 7, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that it has submitted applications seeking approval for SKYRIZI^® (risankizumab-rzaa, 150 mg) to the U.S. Food and Drug Administration (FDA) and for SKYRIZI^® (risankizumab, 150 mg) to the European Medicines Agency (EMA) for the treatment of adults with active psoriatic arthritis.¹ The submissions were supported by two pivotal Phase 3 studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated SKYRIZI in adults with active psoriatic arthritis including those who had responded inadequately or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).¹

"Most patients living with psoriatic arthritis experience both skin and joint disease which can be especially burdensome. Despite advancements, many patients cannot find relief from the signs and symptoms of this disease," said Michael Severino, M.D., vice chairman and president, AbbVie. "We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals."

In the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, SKYRIZI demonstrated significant improvements in disease activity (as measured by ACR20 response and minimal disease activity), skin clearance (as measured by at least a 90 percent improvement in Psoriasis Area Severity Index [PASI 90]) and physical function (as measured by the Health Assessment Questionnaire Disability Index [HAQ-DI]) at week 24 versus placebo.^1* In both studies, significantly more patients treated with SKYRIZI achieved the primary endpoint of ACR20 response at week 24 versus placebo.¹ The safety profile of SKYRIZI in these studies was generally consistent with the safety profile of SKYRIZI in plaque psoriasis, with no new safety risks observed.^1,6-8

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

*Minimal disease activity is defined as the fulfillment of five of seven outcome measures: Tender joint count ≤1; swollen joint count ≤1; PASI ≤1 or body surface area-psoriasis ≤3 percent; Patient's Assessment of Pain Numerical Rating Scale (NRS) ≤1.5; Patient Global Assessment-Disease Activity NRS ≤2.0; HAQ-DI score ≤0.5; and Leeds Enthesitis Index ≤1. Skin symptoms were measured by a 90 percent improvement in the Psoriasis Area Severity Index (PASI 90). Physical function was measured by the HAQ-DI.

About Psoriatic Arthritis

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin.^3,4 In psoriatic arthritis, the immune system creates inflammation that can lead to pain, fatigue, stiffness in the joints and cause a red, scaly rash.^3,4

About KEEPsAKE-1 and KEEPsAKE-2^1,9,10

KEEPsAKE-1 and KEEPsAKE-2 are both Phase 3, multicenter, randomized, double-blind, placebo-controlled studies designed to evaluate the safety and efficacy of SKYRIZI in adult patients with active psoriatic arthritis. KEEPsAKE-1 evaluated SKYRIZI in patients who had an inadequate response or intolerance to at least one DMARD. KEEPsAKE-2 evaluated SKYRIZI in patients who had an inadequate response or intolerance to biologic therapy and/or DMARDs. Patients were randomized to SKYRIZI 150 mg or placebo followed by SKYRIZI 150 mg at week 24. Patients randomized to SKYRIZI received four maintenance doses a year, following two initiation doses.

The primary endpoint for both studies was the achievement of ACR20 response at week 24. Ranked secondary endpoints included change from baseline in HAQ-DI, as well as the achievement of PASI 90 and minimal disease activity (MDA) at week 24. The studies are ongoing, and the long-term extension remains blinded to evaluate the long-term safety, tolerability and efficacy of SKYRIZI in patients who have completed the placebo-controlled period.

More information on these trials can be found at www.clinicaltrials.gov (KEEPsAKE-1: NCT03675308; KEEPsAKE-2: NCT03671148).

About SKYRIZI^® (risankizumab)

SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.^11,12 In April 2019, SKYRIZI received U.S. Food and Drug Administration approval for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. The approved dose for SKYRIZI is 150 mg (two 75 mg injections), administered by subcutaneous injection at week 0 and 4, and every 12 weeks thereafter. SKYRIZI was also approved by the European Commission in April 2019. Phase 3 trials of SKYRIZI in psoriasis, Crohn's disease, ulcerative colitis and psoriatic arthritis are ongoing.^9,10,13-15 Use of SKYRIZI in psoriatic arthritis is not approved and its safety and efficacy have not been established by regulatory authorities.

About SKYRIZI^® (risankizumab-rzaa) in the United States¹²

SKYRIZI is a prescription medicine used to treat adults with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

Important Safety Information¹²

What is the most important information I should know about SKYRIZI^® (risankizumab-rzaa)?

SKYRIZI may cause serious side effects, including infections. SKYRIZI is a prescription medicine that may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

• Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
• fever, sweats, or chills
• muscle aches
• weight loss
• cough
• warm, red, or painful skin or sores on your body different from your psoriasis
• diarrhea or stomach pain
• shortness of breath
• blood in your mucus (phlegm)
• burning when you urinate or urinating more often than normal

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, 
including if you:

• have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?"
• have an infection that does not go away or that keeps coming back.
• have TB or have been in close contact with someone with TB.
• have recently received or are scheduled to receive an immunization (vaccine). You should avoid receiving live vaccines during treatment with SKYRIZI.
• are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SKYRIZI?
SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"

The most common side effects of SKYRIZI include upper respiratory infections, fungal skin infections, headache, feeling tired, and injection site reactions.

These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about
side effects.

Use SKYRIZI exactly as your healthcare provider tells you to use it.

This is not a complete summary of all safety information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

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

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.

Forward-Looking Statements

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie's acquisition of Allergan plc ("Allergan"), failure to promptly and effectively integrate Allergan's businesses, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry and the impact of public health outbreaks, epidemics or pandemics, such as COVID-19. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2020 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References:

1. AbbVie. Data on File: ABVRRTI71470. 
2. Galezowski, A., et al. Rhumatisme psoriasique en France, du nourrisson à la personne âgée : données de deux études transversales multicentriques [Psoriatic arthritis in France, from infants to the elderly: Findings from two cross-sectional, multicenter studies]. Ann Dermatol Venereol. 2018;145(1):13-20. doi:10.1016/j.annder.2017.10.008.
3. Duarte G.V., et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.
4. Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed on April 1, 2021.
5. Psoriatic Arthritis. 2019. Mayo Clinic. Available at: https://www.mayoclinic.org/diseases-conditions/psoriatic-arthritis/symptoms-causes/syc-20354076. Accessed on April 1, 2021.
6. Gordon K., et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25;392(10148):650-661.
7. Reich, K., et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019 Aug 17;394(10198):576-586. doi: 10.1016/S0140-6736(19)30952-3.
8. Blauvelt, A., et al. Efficacy and Safety of Continuous Q12W Risankizumab Versus Treatment Withdrawal: 2-Year Double-Blinded Results from the Phase 3 IMMhance Trial. Poster #478. 24th World Congress of Dermatology. 2019.
9. A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy (KEEPsAKE 1). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/record/NCT03675308. Accessed on April 1, 2021.
10. A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(ies) (KEEPsAKE2). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03671148. Accessed on April 1, 2021.
11. Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
12. SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
13. A Study to Assess the Safety and Efficacy of Risankizumab for Maintenance in Moderate to Severe Plaque Type Psoriasis (LIMMITLESS). ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03047395. Accessed on April 1, 2021. 
14. A Study of the Efficacy and Safety of Risankizumab in Participants With Crohn's Disease. ClinicalTrials.gov. 2021. Available at: https://clinicaltrials.gov/ct2/show/NCT03105102. Accessed on April 1, 2021.
15. A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov. 2020. Available at: https://clinicaltrials.gov/ct2/show/NCT03398148. April 1, 2021.

SOURCE AbbVie

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