Swissmedic: Summary Report on Authorization of Bimzelx®

8 May 2026

Swissmedic has granted an indication extension for Bimzelx® (bimekizumab) to cover the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults who have not responded adequately to systemic antibiotic therapy. Hidradenitis suppurativa is a chronic skin disease characterised by painful nodules and abscesses in skin folds. Bimekizumab works by blocking inflammation-triggering proteins, thereby reducing skin lesions and relieving pain. The authorisation is supported by two clinical studies involving over 1,000 patients, which demonstrated a meaningful reduction in abscesses and inflammatory nodules compared to placebo. This is the third indication extension for Bimzelx in Switzerland, which was originally authorised in 2022 for plaque psoriasis and subsequently extended to axial spondyloarthritis and psoriatic arthritis in 2024.

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