Bimekizumab Under Review for Moderate to Severe Hidradenitis Suppurativa

The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for bimekizumab-bkzx for the treatment of adults with moderate to severe hidradenitis suppurativa (HS). The Agency will also be reviewing an application for the 2mL device presentation of bimekizumab.

Bimekizumab, an interleukin (IL)-17A and IL-17F inhibitor, is currently approved under the brand name Bimzelx^® for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. 

The sBLA is supported by data from the phase 3 BE HEARD I and BE HEARD II studies (ClinicalTrials.gov Identifier: NCT04242446 and NCT04242498, respectively), which included more than 1000 adults with moderate to severe HS (defined as ≥5 inflammatory lesions) who had an inadequate response to a course of a systemic antibiotic. Patients were randomly assigned to receive either bimekizumab or placebo.

The primary endpoint was the percentage of patients who achieved clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50; defined as at least a 50% reduction from baseline in the total abscess and inflammatory nodule count with no increase from baseline in abscess or draining tunnel count) at week 16.

Results from both studies showed patients treated with bimekizumab achieved clinically meaningful improvements in HiSCR50 at week 16 compared with placebo. A greater proportion of patients who received bimekizumab also achieved HiSCR75 at week 16 (key secondary endpoint) vs placebo. 

Post-hoc analysis of the pooled phase 3 data from both trials, showed a greater proportion of bimekizumab-treated patients achieved draining tunnel reductions of 3 or more at week 16 vs placebo (58.0-70.6% vs 35% for placebo), with sustained or improved responses through week 48. Clinically meaningful improvements in skin pain were also noted in bimekizumab patients through week 48.

“The most recent sBLA seeks approval for Bimzelx in moderate to severe hidradenitis suppurativa, and is aligned to our goal of expanding the reach of Bimzelx to more patients living with IL-17–mediated diseases,” said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions, and Head of US, UCB. “In addition, the sBLA for the 2mL device presentations aims to offer increased convenience for patients. Today, 1 dose of Bimzelx in moderate to severe plaque psoriasis is administered as two 1mL injections. Approval of the 2mL device presentations would mean that patients would have an alternative 1-injection regimen option.”