UCB has received the US Food and Drug Administration (FDA) approval for Bimzelx (bimekizumab-bkzx) to treat adults with moderate to severe hidradenitis suppurativa.
Bimzelx is a humanised antibody therapeutic designed to selectively target interleukins 17F (IL-17F), IL-17A and IL-17AF, blocking their interaction with the IL-17RA/IL-17RC receptors.
Hidradenitis suppurativa (HS) is a chronic, recurring, painful and severe inflammatory skin disease, with nodules, abscesses and pus-discharging fistulas as primary symptoms.
It is the fifth indication for Bimzelx in the US, following plaque psoriasis, psoriatic arthritis, non-radiographic axial spondyloarthritis (nr-axSpA), and ankylosing spondylitis (AS).
UCB executive vice president patient impact head and chief commercial officer Emmanuel Caeymaex said: “We are thrilled that with this milestone Bimzelx is now FDA-approved for the treatment of adults with moderate to severe hidradenitis suppurativa, a chronic and painful disease affecting approximately one in 100 people.
“This is the fifth patient population who may benefit from Bimzelx in the US, representing a significant step forward in our mission to alleviate the global burden of immune-mediated inflammatory diseases.
“This progress underscores our commitment to addressing unmet needs in hidradenitis suppurativa and other immunological conditions, delivering innovative medicines and raising standards of care.”
The FDA approval is based on data from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of Bimzelx in 1,014 participants with HS.
The study results showed that a higher proportion of patients treated with Bimzelx achieved more than 50% improvement in HS signs and symptoms at Week 16.
In the studies, the improvement in symptoms is measured by HiSCR50 (hidradenitis suppurativa clinical response), which is the primary endpoint in both trials.
The drug also showed clinically meaningful improvements in the key secondary endpoint, as measured by the HiSCR75, compared to placebo at Week 16, which sustained to Week 48.
Furthermore, Bimzelx showed a safety profile that was consistent with its safety data in previous clinical trials across indications with no new safety signals, said UCB.
BE HEARD studies investigator and lead author of the studies Alexa Kimball said: “The approval of Bimzelx in moderate to severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today.
“In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”
