AbbVie Expands Immunology Portfolio in the U.S. with FDA Approval of SKYRIZI™ (risankizumab-rzaa) for Moderate to Severe Plaque Psoriasis

- Approval based on clinical trials showing people treated with SKYRIZI™ (risankizumab-rzaa) every 12 weeks - four doses a year after two initial doses - achieved high levels of durable skin clearance at 16 weeks and maintained this response at one year[1-3]
- At 16 weeks after two doses, 75 percent of people treated with SKYRIZI achieved 90 percent skin clearance (PASI 90)[1-3]
- At one year, most people (82 and 81 percent) treated with SKYRIZI achieved PASI 90, with the majority (56 and 60 percent) achieving completely clear skin (PASI 100)[1]
- SKYRIZI is expected to be available in the U.S. in early May

News provided by

AbbVie

Apr 23, 2019, 18:19 ET

NORTH CHICAGO, Ill., April 23, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.³ In clinical trials, SKYRIZI produced high rates of durable skin clearance – most people (82 and 81 percent) treated with SKYRIZI achieved 90 percent skin clearance (PASI 90) at one year, with the majority (56 and 60 percent) achieving complete skin clearance (PASI 100).¹

"The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals," said Kenneth B. Gordon, M.D., a principal investigator for the ultIMMa-1 pivotal trial and professor and chair of dermatology at the Medical College of Wisconsin. "In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I'm pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response."

The recommended dose for SKYRIZI is 150mg – administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and 4. SKYRIZI can be administered in-office or by self-injection after training.³

"The approval of SKYRIZI is an important advance in the treatment of adults with plaque psoriasis who are seeking high levels of durable skin clearance that can be maintained over time," said Michael Severino, M.D., vice chairman and president, AbbVie. "SKYRIZI builds on AbbVie's legacy in immunology, expanding our portfolio to help meet the evolving needs in psoriatic disease and reinforcing our continued pursuit of innovations that improve care for people living with immune-mediated conditions."

Affecting 7.5 million Americans, psoriasis is the most prevalent autoimmune disease in the U.S.⁴ It is characterized by over activation of the immune system and widespread inflammation that causes painful, itchy plaques anywhere on the skin.⁵ People with psoriasis also experience a significant emotional, psychological and social burden that can negatively impact their quality of life.⁴

"People living with plaque psoriasis can be profoundly impacted by their disease both physically and emotionally," said Stacie Bell, Ph.D., vice president of research and medical affairs, National Psoriasis Foundation. "The approval of a new therapy represents an important step forward in the treatment of psoriasis, offering dermatologists another option to help patients achieve their treatment goals."

The approval of SKYRIZI is supported by results from AbbVie's global Phase 3 psoriasis program, which assessed the safety and efficacy of SKYRIZI in adults with moderate to severe plaque psoriasis across four randomized, placebo and/or active-controlled pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent. The co-primary endpoints of these studies were Psoriasis Area and Severity Index (PASI 90) and static Physician Global Assessment [sPGA] score of clear or almost clear [sPGA 0/1] at 16 weeks versus placebo.^1-3,6

Highlights across the pivotal studies include:^1,3

In ultIMMa-1 and ultIMMa-2 at 16 weeks, PASI 90 was achieved in 75 percent of people treated with SKYRIZI, compared to 5 and 2 percent receiving placebo, respectively (p<0.001). PASI 100 was achieved in 36 and 51 percent of people treated with SKYRIZI, compared to 0 and 2 percent receiving placebo, respectively (p<0.001).
In ultIMMa-1 and ultIMMa-2 at one year (52 weeks), 82 and 81 percent of people treated with SKYRIZI achieved PASI 90, and 56 and 60 percent achieved PASI 100, respectively (p<0.001).
An integrated analysis of ultIMMa-1 and ultIMMa-2 showed most people treated with SKYRIZI who achieved PASI 90 and PASI 100 at week 16 maintained this response at one year (88 and 80 percent, respectively).

The frequency of adverse events through one year was similar to events observed during the first 16 weeks. The most common adverse events associated with SKYRIZI included upper respiratory infections (13 percent), headache (3.5 percent), fatigue (2.5 percent), injection site reactions (1.5 percent) and tinea infections (1.1 percent). SKYRIZI requires an initial evaluation for tuberculosis (TB) prior to starting treatment, and patients are instructed to report signs and symptoms of infection.³

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

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

AbbVie recently received approval of SKYRIZI from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis, as well as from Health Canada for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. AbbVie also received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorization for SKYRIZI for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy, with a regulatory decision in Europe expected in the first half of this year.

Full prescribing information, including medication guide, can be found here.

More information on SKYRIZI, including full prescribing information, will be available for healthcare professionals soon at www.skyrizihcp.com.

About SKYRIZI³

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.⁷

SKYRIZI is approved in the U.S. and Canada for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and in Japan for the treatment of plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies. A marketing authorization application (MAA) for SKYRIZI for the treatment of patients with moderate to severe plaque psoriasis was submitted to the European Medicines Agency (EMA) in May 2018 and is currently under evaluation.

Phase 3 trials of SKYRIZI in Crohn's disease and psoriatic arthritis are ongoing, and it is also being investigated to treat ulcerative colitis.^8-12

SKYRIZI U.S. Use and Important Safety Information³

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).

What is the most important information I should know about SKYRIZI?
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.

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

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.
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.
SKYRIZI (risankizumab) [Package Insert]. North Chicago, Ill.: AbbVie Inc.
National Psoriasis Foundation. Statistics. https://www.psoriasis.org/content/statistics. Accessed March 8, 2019.
Nature Reviews Disease Primers. Psoriasis. Volume 2. 2016 November. 1-17
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.
Duvallet, E., Sererano, L., Assier, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
Pipeline – Our Science | AbbVie. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on March 8, 2019.
A Study of the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT03105128. Accessed on March 8, 2019.
BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis. ClinicalTrials.gov. Available at: https://clinicaltrials.gov/ct2/show/NCT02719171. Accessed on March 8, 2019.
A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065. ClinicalTrials.gov. 2018. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03398135. Accessed on March 8, 2019.
A Study to Evaluate the Efficacy and Safety of Risankizumab in Subjects With Moderately to Severely Active Ulcerative Colitis Who Have Failed Prior Biologic Therapy. ClinicalTrials.gov. 2018. Available at: https://www.clinicaltrials.gov/ct2/show/NCT03398148. Accessed on March 8, 2019.