CHMP positive for Bimzelx (bimekizumab) for the treatment of active moderate to severe hidradenitis suppurativa.- UCB

If approved by the European Commission (EC), bimekizumab will be the first IL-17A and IL-17F inhibitor approved in the EU for the treatment of adults with moderate to severe HS.

“The positive opinion from the CHMP represents a significant milestone toward bringing bimekizumab to people living with moderate to severe hidradenitis suppurativa, a chronic, painful inflammatory skin disease with limited treatment options,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions, and Head of U.S., UCB. “If approved by the European Commission, this would represent the fourth marketing authorization for bimekizumab in three years, adding to the existing indications in moderate to severe plaque psoriasis, active psoriatic arthritis and active axial spondyloarthritis.”

HS is a chronic inflammatory skin disease that manifests as nodules, abscesses and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin, and buttocks. HS affects approximately one percent of the population in most studied countries with those affected experiencing flare-ups of the disease as well as severe pain. People living with HS also experience social stigma, social isolation and low self-esteem, all of which have a major impact on their quality of life.

The CHMP positive opinion for bimekizumab is based on findings from the Phase III BE HEARD I and BE HEARD II studies which evaluated the efficacy and safety of bimekizumab in the treatment of adults with moderate to severe HS.