The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved UCB’s Bimzelx (bimekizumab) for the treatment of adults with moderate to severe plaque psoriasis.
In a statement, UCB said the MHRA decision makes Bimzelx one of the first medicines to be authorised through the new post-Brexit reliance licensing pathway.
The MHRA approval also closely follows a positive recommendation for the treatment in the plaque psoriasis indication from the National Institute of Health and Care Excellence (NICE).
Similarly, NICE’s appraisal and recommendation for Bimzelx was the first to follow the cost-effectiveness watchdog’s Expedited Low Risk Fast Track Appraisal process.
This new pathway was developed in response to the COVID-19 pandemic, in a bid to accelerate access to new innovative medicines for patients.
“Psoriasis impacts every part of the lives of people living with the condition, from work to relationships. [Bimzelx] 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 [Bimzelx] receive marketing authorisation from the MHRA, offering a highly effective option for patients suffering from moderate to severe plaque psoriasis,” he added.
In the UK, approximately one million people are affected by psoriasis, with about 90% of people living with the condition having plaque psoriasis.
Of those patients, around 2.55% have severe disease – meaning approximately 18,000 severe adult patients are living in England alone.
