Bimekizumab has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), recommending approval of the treatment for moderate-to-severe plaque psoriasis

Bimekizumab – marketed by UCB as Bimzelx – is an investigational IL-17A and IL-17F inhibitor – these two cytokines are believed to be key drivers of inflammatory processes.

The positive CHMP opinion is based on results from three Phase III studies – BE VIVID, BE READY and BE SURE. Each of these studies evaluated the safety and efficacy of bimekizumab in adults with moderate-to-severe plaque psoriasis.

All three studies met their co-primary and ranked secondary endpoints, UCB said in a statement.

In addition, bimekizumab-treated patients achieved superior levels of skin clearance at week 16 compared to patients who receive adalimumab, placebo and ustekinumab.

On top of that, clinical responses achieved with bimekizumab at week 16 were maintained for up to one year across all three studies.

If bimekizumab is granted a marketing authorisation by the European Commission, it could become the first approved treatment for moderate-to-severe plaque psoriasis patients which inhibits both IL-17A and IL-17F, according to UCB. 

“This positive CHMP opinion is a significant regulatory milestone towards approval of bimekizumab in Europe,” said Emmanuel Caeymaex, executive vice president, immunology solutions and head of US, UCB.

“We’re delighted by today’s decision which recognises the strength of the psoriasis clinical development programme. Bimekizumab is testament to our commitment to advancing science in immuno-dermatology, addressing unmet needs and improving patient outcomes,” he added.