UK's MHRA backs UCB's Bimzelx in plaque psoriasis

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Belgium’s largest drugmaker UCB’s (Euronext Brussels: UCB) Bimzelx (bimekizumab) as an option for the treatment of adults with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy.

Psoriasis is a common, chronic immune-mediated systemic disease resulting from sustained inflammation and primarily impacting the skin. This decision makes bimekizumab one of the first medicines to be authorized through the new post-BREXIT reliance licensing pathway.

Health technology assessor the National Institute of Health and Care Excellence (NICE) published its Final Appraisal Document on August 2, 2021, recommending bimekizumab for the treatment of adults with severe plaque psoriasis. The 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 minimize delaying access to new innovative medicines.