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EU nod for Bimzelx for moderate to severe plaque psoriasis

The European Commission (EC) has granted marketing authorisation for UCB’s Bimzelx (bimekizumab) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Bimzelx is the first approved treatment in the European Union (EU) for moderate to severe plaque psoriasis that is designed to selectively and directly inhibit both IL-17A and IL-17F, two key cytokines driving inflammatory processes, according to UCB.

The approval is supported by three Phase III trials where Bimzelx demonstrated superior levels of skin clearance compared to placebo, ustekinumab and adalimumab.

“In the Phase 3b study, treatment with bimekizumab resulted in greater levels of skin clearance than secukinumab. Across studies, about 60 percent of bimekizumab-treated patients achieved complete skin clearance at week 16, and this response was maintained for up to a year.” said professor Richard Warren, Salford Royal NHS Foundation Trust and The University of Manchester, UK.

“We believe that [Bimzelx] has the potential to raise expectations of what psoriasis treatment can deliver,” said Emmanuel Caeymaex, executive vice president, immunology solutions and head of US, UCB.

Bimzelx is currently under US Food and Drug Administration (FDA) review, and regulatory reviews are also underway in Australia, Canada, Great Britain and Japan.