The FDA accepted a supplemental biologics license application (sBLA) for bimekizumab-bkzx (Bimzelx; Union Chimique Belge) for the treatment of moderate-to-severe hidradenitis suppurativa (HS) in adults, according to a press release from the company. Additionally, a second sBLA for Bimzelx 2 mL device presentation was also accepted.1
Bimekizumab-bkzx is a humanized monoclonal immunoglobulin G1 antibody that inhibits interleukin (IL)-17A and IL-17F.2
"We are excited to share progress on our FDA applications. The most recent sBLA seeks approval for [bimekizumab-bkzx] in moderate-to-severe [HS] and is aligned to our goal of expanding the reach of [bimekizumab-bkzx] to more patients living with IL-17–mediated diseases," Emmanuel Caeymaex, executive vice president of Immunology Solutions, and head of US at UCB, said in a press release. "In addition, the sBLA for the 2 mL device presentations aims to offer increased convenience for patients. Today, 1 dose of [bimekizumab-bkzx] in moderate-to-severe plaque psoriasis is administered as 2 1-mL injections. Approval of the 2 mL device presentations would mean that patients would have an alternative 1-injection regimen option."1
HS is a chronic inflammatory skin disease that includes occlusion of hair follicles. In a systemic review and meta-regression analysis published in JAMA Dermatology, the overall prevalence of HS was 0.4%. For studies with clinical samples, the higher pooled prevalence was 1.7% compared to population-based studies at 0.3%, the investigators said.3
The sBLA is supported by data from the phase 3 BE HEARD 1 and BE HEARD 2 studies, demonstrating that bimekizumab-bkzx resulted in clinically meaningful improvements in reduction from baseline in total abscess and inflammatory nodule count by at least 50% without increase in abscess or draining tunnel count (HiSCR50) compared to the placebo at week 16. Furthermore, a greater number of individuals treated with bimekizumab-bkzx compared to the placebo achieved HiSCR75 at week 16, according to the press release.1,2
Both trials included initial treatment from 0 to 16 weeks and maintenance treatment from week 16 to 28. There were 1014 individuals included. Investigators found that by week 48, the responses were either sustained or increased. Patients who switched from the placebo to bimekizumab-bkzx had comparable responses to those who continued treatment with bimekizumab-bkzx, according to an article in Pharmacy Times.2
About The Trials
BE HEARD I
Trial Name: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD I)
ClinicalTrials.gov ID: NCT04242446
Sponsor: UCB Biopharma SRL
Completion Date: February 19, 2023
BE HEARD II
Trial Name: A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa (BE HEARD II)
ClinicalTrials.gov ID: NCT04242498
Sponsor: UCB Biopharma SRL
Completion Date: September 28, 2022
According to the press release, bimekizumab-bkzx had a safety profile consistent with previous studies and no new safety signals were observed. The most common adverse reactions included upper respiratory infections, oral candidiasis, headache, injection site reaction, infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.1
In February 2024, the FDA accepted an sBLA for the drug in 3 spondyloarthritides indications, including psoriatic arthritis, non-radiographic axial spondylarthritis, and ankylosing spondylitis. The FDA also approved the drug in October 2023 for the treatment of moderate-to-severe plaque psoriasis in adults who are eligible for systemic therapies or phototherapies, according to an article from Pharmacy Times.2
References
FDA Accepts Supplemental Biologics License Applications for Bimzelx (bimekizumab-bkzx) for Moderate-to-Severe Hidradenitis Suppurativa and Additional 2mL Device Presentations. News release. UCB. April 4, 2024. Accessed April 4, 2024. https://www.prnewswire.com/news-releases/fda-accepts-supplemental-biologics-license-applications-for-bimzelx-bimekizumab-bkzx-for-moderate-to-severe-hidradenitis-suppurativa-and-additional-2ml-device-presentations-302107800.html
McGovern G. FDA Accepts sBLA For Bimekizumab-Bkzx in 3 New Spondyloarthritides Indications. Pharmacy Times. February 28, 2024. Accessed April 4, 2024. https://www.pharmacytimes.com/view/fda-accepts-sbla-for-bimekizumab-bkzx-in-3-new-spondyloarthritides-indications
Jfri A, Nassim D, O’Brien E, Gulliver W, Nikolakis G, Zouboulis CC. Prevalence of Hidradenitis Suppurativa: A Systematic Review and Meta-regression Analysis. JAMA Dermatol. 2021;157(8):924–931. doi:10.1001/jamadermatol.2021.1677
