The Health Service Executive (HSE) has approved BIMZELEX (bimekizumab) in Ireland for adults living with moderate-to-severe hidradenitis suppurativa (HS) and axial spondyloarthritis (axSpA). The decision provides a new treatment option for patients who have not responded adequately to conventional therapies.
Nadege Feeser, Head of Immunology UCB UK & Ireland, said: “We are thrilled that bimekizumab has been approved by the HSE for patients in Ireland living with two separate chronic diseases. Both hidradenitis suppurativa and axial spondyloarthritis can impact daily life. We firmly believe that every patient deserves to live as free as possible from the challenges and uncertainty of disease, and this recommendation underscores our dedication to supporting people affected by HS and axSpA.”
HS is estimated to affect more than 50,000 people in Ireland. The condition is chronic, recurrent and painful, often appearing in areas containing apocrine sweat glands such as the armpits, breasts, groin and buttocks. Symptoms include redness, swelling and lumps that can lead to abscesses and scarring.
Professor Brian Kirby, Consultant Dermatologist at St Vincent’s University Hospital and Full Clinical Professor at University College Dublin, explained: “Hidradenitis suppurativa creates painful abscesses and scarring on the skin.
He added: “For some patients, existing treatments are not effective, and they are forced to live with a poorly controlled, painful skin disease. It is fantastic to see a much-needed treatment option for individuals impacted by this difficult-to-treat condition, which has very few licensed treatment options available.”
The approval is supported by data from two phase 3 studies, BE HEARD 1 and BE HEARD 2, which assessed 1,014 adult patients with moderate-to-severe HS.
Results showed that significantly more patients treated with bimekizumab achieved a 50 percent or greater improvement in symptoms at week 16 compared with placebo. The safety profile was consistent with previous trials, with no new safety signals observed.
