MHRA authorises UCB’s bimekizumab through new post-Brexit licensing pathway

MHRA authorises UCB’s bimekizumab through new post-Brexit licensing pathway

The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for UCB’s Bimzelx®▼(bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis.

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] and is one of the first treatments to receive marketing authorisation through the new post-Brexit licensing pathway[1,2].

The National Institute of Health and Care Excellence’s (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 III 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]

Claire Brading, Managing Director UK & Ireland, UCB said: “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. 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.”

References

[1] MHRA communication. Bimekizumab MAA. August 2021
[2] NICE Final Appraisal Document. Bimekizumab for treating moderate to severe plaque psoriasis. 2021
[3] NICE Psoriasis treatment pathway. Available at: https://pathways.nice.org.uk/pathways/psoriasis#path=view%3A/pathways/psoriasis/systemic-biological-therapy-for-psoriasis.xml&content=view-node%3Anodes-brodalumab Last accessed: July 2021
[4] Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
[5] Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;10.1056/NEJMoa2102388.
[6] Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.