UCB’s BIMZELX®▼ (bimekizumab) granted marketing authorisation by UK’s MHRA for the treatment of adults with moderate to severe plaque psoriasis

UCB’s BIMZELX®▼ (bimekizumab) granted marketing authorisation by UK’s MHRA for the treatment of adults with moderate to severe plaque psoriasis

 Authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA)

makes it one of the first treatments to receive marketing authorisation through the new post-

BREXIT licensing pathway.1,2

 Bimekizumab is the first treatment authorised by the MHRA to selectively inhibit both IL-17A and

IL-17F for the treatment of adults with moderate to severe plaque psoriasis who are candidates for

systemic therapy 3

 NICE recommended bimekizumab for the treatment of adults with severe plaque psoriasis on 2

August 2021 and is expected to shortly publish its final Technology Appraisal Guidance (TAG)

Slough, United Kingdom, 25th August 2021: Today, the UK’s Medicines and Healthcare products

Regulatory Agency (MHRA) has granted marketing authorisation for UCB’s BIMZELX® (bimekizumab) as

an option for the treatment of adults with moderate to severe plaque psoriasis who are candidates for

systemic therapy. Psoriasis is a common, chronic immune-mediated systemic disease resulting from

sustained inflammation and primarily impacting the skin.2 This decision makes bimekizumab one of the

first medicines to be authorised through the new post-BREXIT reliance licensing pathway*.

The National Institute of Health and Care Excellence (NICE) published its Final Appraisal Document on 2

August 2021, recommending bimekizumab for the treatment of adults with severe plaque psoriasis.2

NICE’s appraisal and recommendation for bimekizumab was the first to follow the 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.

NICE is expected to publish its final Technology Appraisal Guidance (TAG) shortly, at which point

bimekizumab will be available to patients in England and Wales within four weeks.

The authorisation is supported by results from three Phase 3 studies, BE VIVID, BE READY and BE

SURE,2 which demonstrated the superior efficacy of bimekizumab in adults with moderate to severe

plaque psoriasis against placebo, ustekinumab and adalimumab at 16 weeks.4,5,6

“We are pleased to have received marketing authorisation for bimekizumab from the MHRA and look

forward to making this new treatment option available to patients in England, Scotland and Wales,” said

Claire Brading, Managing Director UK & Ireland, UCB. “We have witnessed first-hand the mental

strength and resilience needed to live with this condition. Our belief is that success comes from putting

people living with health conditions at the very heart of medicines development, from discovery, through

R&D, to marketing authorisation and beyond.”

*For a period of two years from 1 January 2021, when determining an application for a Great Britain Marketing Authorisation (MA), the

MHRA may rely on a decision taken by the European Commission (EC) on the authorisation of a new MA in the centralised procedure.

Great Britain refers to England, Scotland and Wales.

Psoriasis affects approximately one 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 disease equating to

approximately 18,000 severe adult patients in England.8,9 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

Today’s decision from the MHRA makes bimekizumab the first treatment available to patients in the UK

that selectively inhibits two key cytokines, IL-17A and IL-17F, which aid cell to cell communication in

immune responses11 and help drive inflammatory processes for moderate to severe plaque psoriasis.3 IL-

17A and IL-17F are key drivers of chronic tissue inflammation so targeting both cytokines is believed to

help suppress inflammation in patients.10

“Psoriasis impacts every part of the lives of people living with the condition, from work to relationships.

Bimekizumab has shown strong results in head-to-head trials with higher rates of skin clearance

achieved versus some of the most prescribed therapies, a key outcome for patients,” said Professor

Richard Warren, Consultant Dermatologist, Salford Royal NHS Foundation Trust. “It is fantastic to see

bimekizumab receive marketing authorisation from the MHRA, offering a highly effective option for

patients suffering from moderate to severe plaque psoriasis.”