AbbVie Announces First Regulatory Approval of SKYRIZI™ (risankizumab) for the Treatment of Plaque Psoriasis, Generalized Pustular Psoriasis and Erythrodermic Psoriasis and Psoriatic Arthritis in Japan

NORTH CHICAGO, Ill., March 26, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved SKYRIZI™ (risankizumab), an interleukin-23 (IL-23) inhibitor, 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. This approval marks the first country approval in the world for SKYRIZI.

"With this first global approval of SKYRIZI, we are excited to bring a new treatment option to people living with psoriatic disease in Japan," said Michael Severino, M.D., vice chairman and president, AbbVie. "SKYRIZI has the potential to improve the signs and symptoms of these chronic, immune-mediated diseases. We look forward to continuing to work with regulatory authorities to make this treatment available to more patients worldwide."

Psoriasis is a chronic, non-communicable inflammatory condition characterized by inflamed, scaly patches that typically causes people to experience itchiness, burning and stinging.^2,3 Psoriasis is linked to several associated conditions, and in Japan, as many as 15 percent of individuals with psoriasis also develop psoriatic arthritis, a chronic, inflammatory disease that leads to irreversible joint deformations and disability.⁴ Worldwide, as many as 30 percent of people living with psoriasis may develop psoriatic arthritis.³

"Advances in our understanding of psoriatic disease have brought us to an era where clear skin is a realistic treatment goal," said Mamitaro Ohtsuki, M.D., Ph.D., Chairman and Professor, Department of Dermatology, Jichi Medical University. "SKYRIZI has the potential to help psoriasis patients achieve high rates of skin clearance bringing them closer to reaching long-term treatment goals with every 12-week dosing."

The approval is based on efficacy and safety data from Phase 2 and Phase 3 clinical trials, sustaIMM, ultIMMa-1 and IMMspire, evaluating SKYRIZI in Japanese patients with plaque psoriasis, generalized pustular psoriasis and erythrodermic psoriasis, as well as a global Phase 2 study in patients with active psoriatic arthritis. More information can be found on www.clinicaltrials.gov.

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

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for SKYRIZI for treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy in February 2019. SKYRIZI is currently under review with the U.S. Food and Drug Administration (FDA) and a regulatory decision is anticipated in the first half of 2019.

About SKYRIZI™ (risankizumab) in Japan

SKYRIZI is approved for the treatment of psoriasis vulgaris, psoriatic arthritis, generalized pustular psoriasis, or erythrodermic psoriasis in adult patients who responded inadequately to conventional therapies.

Important Safety Information

Warnings
SKYRIZI is associated with increased risks of infections and may activate tuberculosis in patients with a history of tuberculosis. There have also been reports of malignant tumors, although it is unclear whether they are causally related to SKYRIZI. Before starting treatment with SKYRIZI, fully consider the use of phototherapies or other existing systemic therapies (except biologics).

Contraindications
SKYRIZI is contraindicated in patients with serious infection, active tuberculosis, or with a history of hypersensitivity to any of the ingredients of SKYRIZI.

Precautions for Use
SKYRIZI is associated with increased risk of infections. Thus, patients undergoing treatment with SKYRIZI should be observed carefully, with attention paid to any onset or worsening of infections. Additional attention should be paid to the occurrence of side effects, including infections, in the elderly.

Before administering SKYRIZI, confirm whether a patient has a tuberculous infection by detailed medical interview about tuberculosis and performing a chest X-ray exam, an interferon-γ release assay or a tuberculin test, or a chest CT scan, as appropriate, among other tests.

A risk of developing infection associated with live vaccines cannot be ruled out. Thus, no live vaccines are to be given to patients undergoing treatment with SKYRIZI.

The safety and efficacy of the concomitant use of SKYRIZI and other biologic have not been established and, therefore, should be avoided. Also, if another biologic is switched to SKYRIZI, the patient should be carefully monitored for signs of infection.

Occurrence of skin malignancy and malignancies other than skin are reported from clinical studies.

Adverse Reactions
Clinically significant adverse reactions were serious infection (sepsis, osteomyelitis, pyelonephritis and meningitis bacterial) (0.7%) and serious hypersensitivity (0.1%) such as anaphylaxis. Adverse reactions ≥1% were upper respiratory tract infection, tinea infection, headache and injection site reaction.

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. Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.
2. World Health Organization. Global Report on Psoriasis. 2016. Available at: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf. Accessed on February 6, 2019.
3. National Psoriasis Foundation website. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed on February 6, 2019.
4. Yamamoto et al. J Dermatol.;45: 273-278, 2018.

SOURCE AbbVie

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