SKYRIZI™▼(risankizumab) Receives NICE Positive Technology Appraisal Guidance for the Treatment of Plaque Psoriasis in Adults

MAIDENHEAD, UK, 21 August 2019 - AbbVie (NYSE: ABBV), a research-based biopharmaceutical company, announces that eligible patients in England and Wales with plaque psoriasis who have failed conventional systemic therapies will have access to SKYRIZI™▼(risankizumab) following the issuing by the National Institute for Health and Care Excellence (NICE) of the Technology Appraisal Guidance (TAG) recommending the treatment¹.

The TAG represents the completion of the final step of NICE assessment and follows a positive recommendation by NICE through its Fast Track Appraisal process, which has an accelerated timeframe of 30 days for implementation rather than the usual 90 days associated with a Single Technology Appraisal.

Plaque psoriasis is a chronic condition affecting an estimated 820,000 people in the UK and many patients still do not reach treatment goals or lose treatment response over time^2-4. In clinical studies risankizumab demonstrated high rates of skin clearance at 16 weeks and this clearance was also maintained through to one year (52 weeks).⁵

This announcement means that risankizumab will be made available to eligible patients almost two months earlier than would have been the case via other NICE assessment routes.

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

About risankizumab in the UK

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information⁶

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients with clinically important active infections (e.g. tuberculosis). 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.

▼Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc . Globally, prescribing information varies; refer to the individual country product label for complete information.

-Ends-

UK Media:

Sarah Beck

+44 (0)7818 428111

Sarah.beck@abbvie.com

References:

¹ The Technology Appraisal Guidance (TAG) can be accessed via the NICE website

² 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

³ 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

⁴ National Institute for Health and Care Excellence. Resource impact template: Brodalumab for treating moderate to severe plaque psoriasis (TA511). March 2018, available at: www.nice.org.uk/guidance/ta511/resources/resource-impact-template-excel-4786962589 (accessed August 2019)

⁵ 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

⁶ SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.medicines.org.uk/emc