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Bimekizumab becomes first treatment with positive recommendation through expedited NICE review process

Bimekizumab becomes first treatment with positive recommendation through expedited NICE review process

• Bimekizumab is the first medicine to be recommended through NICE’s new Expedited Low-Risk Fast Track Appraisal (FTA) process1

• The treatment is the first treatment recommended by NICE to selectively inhibit both IL-17A and IL-17F for the treatment of adults with severe plaque psoriasis2

• Bimekizumab is currently awaiting approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) which is anticipated in the next few months

Slough, United Kingdom, 2 August 2021: Today, the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination, recommending UCB’s bimekizumab as an option for the treatment of adults with severe plaque psoriasis, a common, chronic immune-mediated systemic disease resulting from sustained inflammation and primarily impacting the skin.1

This recommendation is the first to follow NICE’s new Expedited Low Risk Fast Track Appraisal process, a pathway developed in response to the COVID-19 pandemic to minimise delaying access to new innovative medicines. This pathway allows a subset of the appraisal committee to make a recommendation based on the evidence included in the initial submission made by the company and assessed by the Evidence Review Group, without the need for a full committee meeting.

NICE’s recommendation for bimekizumab underscores UCB’s commitment to achieving patient access to innovative medicines by demonstrating value to patients, healthcare systems, and society. NICE noted from the company network meta-analysis that bimekizumab was more effective than three comparator treatments (brodalumab, risankizumab and ixekizumab) in PASI 90 and 100 response (a way to measure severity and extent of psoriasis).

The recommendation is also supported by results from four Phase 3 studies, BE VIVID, BE RADIANT (Phase 3b), BE READY and BE SURE,1 which demonstrated the superior efficacy and safety of bimekizumab in adults with moderate to severe plaque psoriasis against placebo, ustekinumab, secukinumab and adalimumab.3-6

“This fast-tracked NICE decision marks a significant moment for innovative medicines in the UK and reinforces our commitment to advancing science in immuno-dermatology,” said Claire Brading, Managing Director UK & Ireland, UCB. “Designed and developed here in the UK, bimekizumab has shown significant sustained improvements in psoriasis severity in both head-to-head and placebo controlled clinical trials. We’re proud to have worked so collaboratively with NICE throughout this process to help speed up access to this important treatment.”

UCB is anticipating a decision on marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the next few months, which would make it one of the first medicines to be considered through the new post-BREXIT approval pathway. Once the MHRA approval is received, NICE will issue final technology appraisal guidance (TAG) and bimekizumab will become available to patients in England and Wales.

Psoriasis affects approximately 1 million people in the UK.7 About 90% of people in the UK with the condition have plaque psoriasis and of those, about 2.55% have severe disease8 equating to approximately 18,000 severe adult patients in England.9 Unfortunately, the unmet need remains in psoriasis with the visible symptoms impacting the day-to-day lives of those living with the condition, including employment, significant physical, psychological, social isolation and economic burden which may result in failure to achieve full life potential.10

This decision by NICE means bimekizumab will be the first recommended treatment by NICE to selectively inhibit two key cytokines, IL-17A and IL-17F, which aid cell to cell communication in immune responses11 and drive inflammatory processes for severe plaque psoriasis.2 IL-17A and IL-17F are key drivers of chronic tissue inflammation so neutralising both cytokines is believed to suppress inflammation in patients.11

“People living with psoriasis in the UK are in need of innovative treatments that improve the visible elements of the condition. Having psoriasis can have an impact on wellbeing with patients often reporting a lack of confidence and low self-esteem,” said Helen McAteer, Chief Executive of The Psoriasis Association, and NICE consultee for this decision. “The Psoriasis Association welcomes this important decision and is pleased that NICE is exploring new processes to improve patient access to effective treatments.”

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Last Updated: 03-Aug-2021