Global biopharmaceutical company, UCB, recently announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for BIMZELX® (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS). Additionally, the FDA has also approved a second sBLA for the bimekizumab-bkzx 2mL autoinjector device.
BIMZELX is an IL-17A and IL-17F inhibitor and was previously approved in October 2023 for the treatment of moderate-to-severe plaque psoriasis.
This newly accepted sBLA is supported by data from the Phase 3 BE HEARD I and BE HEARD II studies which evaluated the safety and efficacy of bimekizumab-bkzx in adults with moderate-to-severe HS. The two multicenter, randomized, double-blind, placebo-controlled studies included a total of 1,014 participants. The primary endpoint was an improvement from baseline in the HS Clinical Response (HiSCR50) at Week 16 and secondary endpoint of HiSCR75 at Week 16.
Results demonstrated a significant improvement in HiSCR50 at Week 16 compared to placebo. In addition, a greater proportion of patients also achieved HiSCR75 at Week 16 compared to placebo. These results were maintained over a 48-week period.
The bimekizumab-bkzx 2mL safety syringe and 2mL autoinjector hopes to provide a second option to the current 1mL presentations.
“We are excited to share the progress on our FDA applications. The most recent sBLA seeks approval for bimekizumab-bkzx in moderate to severe hidradenitis suppurativa and is aligned to our goal of expanding the reach of bimekizumab to more patients living with IL-17 mediated diseases. In addition, the sBLA for the 2mL device presentations aims to offer increased convenience for patients. Today, one dose of bimekizumab 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 one injection regimen option.”
