New SKYRIZI [® ]▼ (risankizumab) 150 mg Presentation Pre-filled Pen and Pre-filled Syringe Approved by the Medicines and Healthcare Products Regulatory Agency (MHRA)
- Risankizumab is now administered as one injection per dose, either by pre-filled pen or pre-filled syringe1
- Approval based on results showing the new formulation of risankizumab 150 mg demonstrated bioequivalence to two injections of risankizumab 75 mg1
MAIDENHEAD, UK, June 4, 2021 – AbbVie (NYSE: ABBV) today announced the Medicines and Healthcare Products Regulatory Agency (MHRA) has approved a new risankizumab 150 mg presentation, to be administered by one injection per dose via pre-filled pen or pre-filled syringe every 12 weeks following an initiation dose at week 0 and week 4.1 Originally approved to be administered by two 75 mg subcutaneous injection doses, this additional approval reduces the number of injections per year by half for the same therapeutic amount per dose as the two 75mg dosing.1
“Since its approval, risankizumab has made an impact on the psoriasis treatment landscape, offering many people living with moderate to severe plaque psoriasis a meaningful treatment option,” said Belinda Byrne, AbbVie UK Medical Director. “This approval marks a significant milestone in our ongoing pursuit to address the challenges people living with psoriasis experience, giving patients and their healthcare providers more options on their treatment journey."
This approval, which follows the recent European Commission approval, was based on results showing the single risankizumab 150 mg injection met the primary endpoint and demonstrated bioequivalence to the two injections of the risankizumab 75 mg pre-filled syringe.1 In addition, the risankizumab 150 mg pre-filled pen showed bioequivalence to the risankizumab 150 mg prefilled syringe.1
The recent EC approval grants marketing authorisation in all EU member states (including Iceland, Liechtenstein, Norway and Northern Ireland). The MHRA grants marketing authorisation in Great Britain.
Risankizumab is part of a collaboration with Boehringer Ingelheim, with AbbVie leading development and commercialisation of risankizumab globally.
Psoriasis is a chronic, immune-mediated disease that causes inflamed, scaly patches to appear on the skin that can cause pain and discomfort.2 Affecting at least 100 million people worldwide, people with psoriasis often experience flaking, scaling and nail changes.2,3
Risankizumab is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.1,4 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.1,4 In April 2019, risankizumab was approved by the European Commission for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. The recommended dose of risankizumab is 150 mg administered as a subcutaneous injection at week 0, week 4 and every 12 weeks thereafter. 1
Important safety information1
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 immunisations should be considered according to current immunisation 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.
▼ Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AbbVie UK Ltd. Please contact GBPV@abbvie.com.
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.
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SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at https://www.medicines.org.uk/emc/ Accessed May 2021.
- World Health Organization. Global Report on Psoriasis. 2016. Available at: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf. Accessed February, 2021.
- International Federation of Psoriasis Associations. Psoriasis is a Serious Disease Deserving Global Attention. Available at: https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed February 2021.
- Duvallet, E., et al. Interleukin-23: a key cytokine in inflammatory diseases. Ann Med. 2011 Nov;43(7):503-11.
About AbbVie UK
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. The company strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on Twitter, YouTube.