FDA
Bimzelx (bimekizumab-bkzx) now approved for hidradenitis suppurative
Brand name: Bimzelx
Generic name: bimekizumab-bkzx
Manufacturer: UCB
Approval date: November 20, 2024
FDA approved Bimzelx (bimekizumab-bkzx) for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). Previously the drug was approved for the treatment of psoriasis, psoriatic arthritis, axial spondylitis, and ankylosing spondylitis in adults.
Efficacy
Approval was supported by data from the phase 3 BE HEARD I and BEHEARD II trials, in which a higher proportion of patients treated with Bimzelx vs. placebo achieved ≥50% improvement in HS signs and symptoms at week 16, as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), the primary endpoint in both trials. Bimzelx also resulted in clinically meaningful improvements in the key secondary endpoint, HiSCR75, vs. placebo at week 16. Clinical responses were sustained to week 48.
Safety
The most commonly reported adverse reactions in patients with psoriasis or HS (incidence ≥1%) are upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, herpes simplex infections, acne, folliculitis, other candida infections, and fatigue.
Recommended dose
The recommended dose of Bimzelx for moderate to severe HS in adults is 320 mg SC at weeks 0, 2, 4, 6, 8, 10, 12, 14, and 16, then q4wks thereafter.
Source:
UCB. (2024, November 20). UCB receives U.S. FDA approval for BIMZELX (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa. [Press release]. https://www.ucb.com/stories-media/Press-Releases/article/UCB-receives-US-FDA-approval-for-BIMZELXR-bimekizumab-bkzx-as-the-first-IL-17A-and-IL-17F-inhibitor-for-adults-with-moderate-to-severe-hidradenitis-suppurativa
UCB: Bimzelx (bimekizumab-bkzx) [Package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761151s010lbl.pdf
Kimball AB, et al. (2024, June 8). Lancet. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48-week, randomised, double-blind, placebo-controlled, multicentre phase 3 trials. https://pubmed.ncbi.nlm.nih.gov/38795716/