UCB announces EMA bimekizumab verdict

In two studies the therapy demonstrated improvements when compared with the placebo

UCB has announced that the European Medicines Agency (EMA) has accepted, for review, the marketing authorisation application for its bimekizumab candidate. The therapy is an IL-17A and IL-17F inhibitor for the treatment of patients with moderate-to-severe hidradenitis suppurativa (HS).

This critical application for HS is backed up by data from the phase 3 ‘BE HEARD I’ and ‘BE HEARD II’ trials. Indeed, in each study, bimekizumab demonstrated significant and clinically meaningful improvements when compared with the placebo.

Furthermore, the safety profile of bimekizumab across both studies was consistent with previous studies, with no new safety signals observed.

In 2021, bimekizumab first received marketing authorisation in countries belonging to the EU or European Economic Area (EEA) to treat moderate-to-severe plaque psoriasis among adults who are candidates for systemic therapy.

Meanwhile, in June this year, the drug was subsequently approved in countries of the EU/EEA for the treatment of adults with active psoriatic arthritis and to treat individuals with active axial spondyloarthritis (axSpA), including non-radiographic axSpA and ankylosing spondylitis.

Emmanuel Caeymaex, executive vice president, immunology solutions at UCB, was enthusiastic about the therapy’s chances, following the EMA verdict: “This EU regulatory submission for bimekizumab reflects our pursuit to address unmet patient needs and to advance standards of care in hidradenitis suppurativa (HS), especially given that few treatment options are available today.”

He added: “If approved, this would represent the fourth indication for bimekizumab in the EU across a range of IL-17 mediated diseases.”

Currently, the safety and efficacy of bimekizumab among individuals living with HS have not been completely established and the drug is, therefore, not approved for use in HS by any international regulatory authorities.

HS is a chronic, inflammatory skin condition, which is often painful and associated with systemic manifestations. It impacts around one in 100 people aworldwide.