UCB’s BIMZELX (bimekizumab) receives expedited acceptance from Scottish Medicines Consortium (SMC) for the treatment of plaque psoriasis

• Bimekizumab has received acceptance through the Scottish Medicines Consortium’s (SMC) fast- track process1

• The first treatment accepted by the SMC to selectively inhibit both IL-17A and IL-17F for the treatment of adults with moderate to severe plaque psoriasis1,2

• Eligible patients in Scotland will now be able to access this new treatment option for their psoriasis1

Slough, United Kingdom, 8th November 2021: Today, the Scottish Medicines Consortium (SMC) has accepted BIMZELX® (bimekizumab) for use by NHS Scotland as a treatment option for adults with moderate to severe plaque psoriasis who are candidates for systemic therapy and have failed to respond to standard systemic therapies, are intolerant to, or have a contra-indication to these treatments. This acceptance was expedited through SMC’s fast track process, taking a total of 4 months and 3 days from submission to acceptance.1 This fast-track process was set up in response to the Covid-19 pandemic, to minimise delays in patient access to new medicines.3

Psoriasis is a common, chronic, immune-mediated, systemic disease resulting from sustained inflammation, which primarily impacts the skin. Bimekizumab is the first available treatment in Scotland that selectively inhibits two key inflammatory cytokines, IL-17A and IL-17F. 1,2 These cytokines aid cell to cell communication in immune responses and help drive inflammatory processes. Given their role in driving chronic tissue inflammation, targeting both cytokines is believed to help suppress inflammation in patients.2

“Patients with psoriasis and Dermatologists in Scotland welcome the SMC's recommendation of bimekizumab for the treatment of moderate to severe psoriasis in candidates for systemic therapy. This monoclonal antibody is a significant addition to the family of Th17 pathway inhibitors for the treatment of psoriasis with the benefit of dual inhibition of IL-17A and IL-17F. With a rapid onset of action, bimekizumab achieves high rates of clearance among treated patients with an advantageous maintenance dosing every 8 weeks. This high performance has been demonstrated even in patients with previous treatment experience with more than one biological agents, widening the management options for all patients with psoriasis,” said Dr Areti Makrygeorgou, Associate Specialist Dermatologist, West Ambulatory Care Hospital, Glasgow.

Psoriasis affects approximately one million people in the UK.4 About 90% of people in the UK with the condition have plaque psoriasis and of those, about 2.55% have severe disease.5 Within Scotland, approximately 3,060 in every 100,000 people has psoriasis.6 Psoriasis can have a serious and ongoing impact on the day-to-day lives of those living with the condition, across physical and psychological wellbeing, work, and social life. The wide-ranging impact may impede the person’s ability to achieve their full life potential.7

“Psoriasis remains a difficult condition to treat, with the impact of the disease often extending beyond the skin, damaging people’s confidence and self esteem. The Psoriasis Association are pleased that SMC have accepted this treatment through the fast-track process, which helps to improve patient access to effective treatments,” said Helen McAteer, Chief Executive of The Psoriasis Association.

The acceptance by SMC is supported by results from three Phase 3 studies, BE VIVID, BE READY and BE SURE, which demonstrated the superior efficacy of bimekizumab in adults with moderate to severe 2 Bimekizumab receives expedited acceptance from SMC GB-N-BK-PSO-2100099 | November 2021 plaque psoriasis against placebo, ustekinumab and adalimumab at 16 weeks.8 Efficacy was indicated by PASI scores, which represent the level of skin clearance.9,10,11

Authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) was received on 25 August 2021, which marks bimekizumab as one of the first treatments to receive marketing authorisation through the new post-Brexit reliance approval pathway.12

Bimekizumab is already available to adults with moderate to severe plaque psoriasis in England and Wales following the National Institute of Health and Care Excellence (NICE) publishing its final Technology Appraisal Guidance (TAG) on 1 September 2021.13

“UCB recognises and understands the impact chronic inflammatory skin disorders, such as psoriasis, can have on people, the health care system and wider society. We are committed in continuing to drive life changing improvements in the way these conditions are managed in the UK and Ireland,” said Claire Brading, Managing Director UK & Ireland, UCB.