European Commission Approves SKYRIZI™ (risankizumab) for the Treatment of Moderate to Severe Plaque Psoriasis

NORTH CHICAGO, Ill., April 30, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the European Commission (EC) has approved SKYRIZI™ (risankizumab) for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy. SKYRIZI (150 mg) is approved to be administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and week 4. In clinical studies, SKYRIZI demonstrated high rates of skin clearance at 16 weeks and this clearance was durable at one year (52 weeks).^1-4 This approval allows for the marketing of SKYRIZI in all member states of the European Union, as well as Iceland, Liechtenstein and Norway.

"This approval is an important step forward in providing people living with moderate to severe psoriasis with a new treatment option," said Michael Severino, M.D., vice chairman and president, AbbVie. "The results seen in our clinical studies, including high levels of complete skin clearance with 12-week dosing and a favorable safety profile, suggest SKYRIZI has the potential to provide long-term relief from the signs and symptoms of psoriasis. We are proud to expand our portfolio of treatment options for people living with this condition in Europe."

"In clinical studies, patients saw significantly higher rates of skin clearance with SKYRIZI compared to current standards of care," said Hervé Bachelez, professor at the University Paris Diderot and the Department of Dermatology of the Saint-Louis Hospital-Assistance Publique Hôpitaux de Paris, France and a principal investigator of the ultIMMa-2 study. "As many as 80 percent of patients who achieved clear skin at 16 weeks maintained completely clear skin through one year. We look forward to seeing more of the two-year data from the IMMhance study at the World Congress of Dermatology in June."

SKYRIZI received EC approval based on results from four pivotal Phase 3 studies, ultIMMa-1, ultIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.^1-4 Across all four studies, the co-primary endpoints were 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) at week 16.^1-4 SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

Highlights from the pivotal Phase 3 program

• In the ultIMMa-1 and ultIMMa-2 studies, SKYRIZI met the co-primary endpoints of sPGA 0/1 and PASI 90 at week 16 (p<0.001).^1,4 After 16 weeks of treatment, 88 percent (ultIMMa-1) and 84 percent (ultIMMa-2) of SKYRIZI patients achieved sPGA 0/1 and 75 percent of patients receiving SKYRIZI in both studies achieved PASI 90.^1,4
• An integrated analysis of patients who received SKYRIZI in the ultIMMa-1 and ultIMMa-2 studies showed that, of patients who achieved PASI 90 with SKYRIZI at week 16, 88 percent of these patients maintained PASI 90 with SKYRIZI at one year (52 weeks). Of patients who achieved PASI 100 with SKYRIZI at week 16, 80 percent maintained PASI 100 with SKYRIZI at one year (52 weeks).⁴
• SKYRIZI demonstrated superiority versus adalimumab in the IMMvent study, with 72 percent of patients achieving PASI 90 compared to 47 percent of patients treated with adalimumab at week 16 (p<0.001).^2,4 Following re-randomization at week 16, 66 percent of patients who started on adalimumab and switched to SKYRIZI achieved PASI 90, compared to 21 percent who continued on adalimumab at week 44 (p<0.001).^2,4 The co-primary endpoints of sPGA 0/1 and PASI 90 at week 16 were met (p<0.001).^2,4
• Results from IMMhance showed that, among people receiving SKYRIZI who achieved clear or almost clear skin (sPGA 0/1) response at week 28 and were re-randomized to continue SKYRIZI (n=111), 87 percent maintained this response at week 52 compared to 61 percent re-randomized to withdraw (n=225).⁹ The co-primary endpoints of sPGA 0/1 at week 16 and week 52 were met (p<0.001).^3,4
• SKYRIZI was also reported to improve health-related quality of life in Phase 3 studies. In ultIMMa-1 and ultIMMa-2, significantly more patients treated with SKYRIZI self-reported a Dermatology Life Quality Index (DLQI) score of 0 or 1 (75 percent in ultIMMa-1 and 71 percent in ultIMMa-2) compared with ustekinumab (47 percent in ultIMMa-1 and 44 percent in ultIMMa-2) at one year (p<0.001).^1,4 DLQI is a measure of a patient's health-related quality of life, ranging from 0 to 30, with lower scores indicating the disease has less impact on life quality.¹⁰

More information about this program can be found on www.clinicaltrials.gov (NCT02672852, NCT02694523, NCT02684370, NCT02684357).

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients.⁴ Common adverse reactions (frequency defined as greater than or equal to 1/100 events to less than 1/10) included tinea infections, headache, pruritus, fatigue and injection site reactions.⁴

AbbVie received approval of SKYRIZI from the Japanese Ministry of Health, Labour and Welfare for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in March 2019, as well as approval for the treatment of adults with moderate to severe plaque psoriasis from Health Canada and the U.S. Food and Drug Administration in April 2019.

About SKYRIZI (risankizumab) in the European Union

SKYRIZI (risankizumab) is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information⁴

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at www.ema.europa.eu. Globally, prescribing information varies; refer to the individual country product label for complete information.

About HUMIRA^® (adalimumab) in the European Union

HUMIRA is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

Important EU Safety Information¹¹

HUMIRA is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients; serious allergic reactions including anaphylaxis have been reported. The use of HUMIRA increases the risk of developing serious infections, including hepatitis B reactivation, which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukemia have been reported in patients treated with HUMIRA. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with HUMIRA. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

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

Full summary of product characteristics is available at: www.ema.europa.eu

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, LinkedIn or Instagram.

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, competition from other products, challenges to intellectual property, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 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 2018 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. 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. 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.
2. Reich, K., et al. Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813. European Academy of Dermatology and Venereology Congress. 2018.
3. Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30.
4. SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu.  
5. Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
6. International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22, 2019.
7. Mroweitz, U., et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10.
8. Levin, et al. Biologic fatigue in psoriasis. J Dermatolog Treat. 2014 Feb;25(1):78-82. doi: 10.3109/09546634.2013.826341.
9. Langley, et al. Efficacy and Safety of Continuous Q12W Risankizumab versus Treatment Withdrawal: Results from the Phase 3 IMMhance Trial. Poster #10093. 2019 American Academy of Dermatology Annual Meeting. 2019.
10. Hongbo Y, et al. Translating the science of quality of life into practice: What do dermatology life quality index scores mean? J Invest Dermatol. 2005 Oct;125(4):659-64.
11. HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Last updated October 5, 2017. Accessed March 22, 2019.

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