UCB’s Bimzelx (bimekizumab-bkzx) has received FDA approval for the treatment of active moderate-to-severe hidradenitis suppurativa (HS) in adult patients. This decision marks a significant advancement for individuals affected by this chronic inflammatory skin condition, which is estimated to impact approximately one in every 100 people in the United States.
The approval is supported by data from the pivotal Phase 3 BE HEARD I and BE HEARD II trials. These studies demonstrated that a significantly higher proportion of patients treated with Bimzelx achieved at least a 50% improvement in HS signs and symptoms, as measured by the Hidradenitis Suppurativa Clinical Response (HiSCR50), at week 16 compared to placebo. Furthermore, treatment with Bimzelx led to clinically meaningful improvements in the high threshold endpoint, HiSCR75, at week 16, with sustained clinical responses observed through week 48.
Clinical Trial Data
The BE HEARD I and II trials were crucial in establishing the efficacy and safety profile of Bimzelx for HS. The primary endpoint of HiSCR50 at week 16 was met with statistical significance in both trials. Key secondary endpoints, including HiSCR75, also showed significant improvements in the Bimzelx-treated groups compared to placebo. These results underscore the potential of Bimzelx to provide substantial relief for patients suffering from moderate-to-severe HS.
Mechanism of Action
Bimzelx is a monoclonal antibody designed to selectively inhibit two key cytokines, IL-17A and IL-17F, which are known to drive inflammatory processes. By blocking these cytokines, Bimzelx helps to reduce the inflammation associated with HS, leading to improvements in the signs and symptoms of the disease. Bimzelx is already approved in the US for the treatment of plaque psoriasis, psoriatic arthritis, axial spondyloarthritis, and ankylosing spondylitis.
Addressing Unmet Needs in HS Treatment
Hidradenitis suppurativa is a chronic, debilitating skin disease characterized by nodules, abscesses, and pus-discharging fistulas. Many patients experience frequent flare-ups and severe pain, significantly impacting their quality of life. Current treatment options are limited, and many patients do not achieve adequate control of their symptoms with existing therapies. The approval of Bimzelx offers a new therapeutic option for these patients, addressing a significant unmet medical need.
Expert Commentary
Alexa Kimball, investigator and lead author of the BE HEARD I and II studies from Harvard Medical School, stated, “The approval of Bimzelx in moderate-to-severe HS is welcome given the substantial unmet clinical needs and limited number of treatment options available today.” Brindley Brooks, founder and executive director of HS Connect, added, “[The] approval of [Bimzelx] is an exciting time for the HS community, offering a new possibility for the treatment of people in the US living with moderate-to-severe disease.”
