Headlines in Dermatology | Hidradenitis Suppurativa

U.S. FDA Approves Bimekizumab-bkzx (Bimzelx, UCB) for HS

November 20, 2024

The U.S. Food and Drug Administration (FDA) has approved bimekizumab-bkzx (Bimzelx, UCB) for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS).

Bimekizumab, an interleukin 17F (IL-17F) and IL-17A blocker, is now the third medication approved for HS, joining adalimumab (Humira, AbbVie) and its biosimilars and secukinumab (Cosentyx, Novartis).

“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,” says investigator and lead author of the studies, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology at Harvard Medical School, Boston, MA, in s news release. “In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”

“We are working toward a world where people with hidradenitis suppurativa live without stigma, feel widely understood, and are treated effectively. Today’s approval of bimekizumab-bkzx is an exciting time for the hidradenitis suppurativa community, offering a new possibility for the treatment of people in the U.S. living with moderate-to-severe disease,” says Brindley Brooks, Founder and Executive Director of HS Connect.

The approval of bimekizumab-bkzx blocker is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of bimekizumab in the treatment of adults with moderate-to-severe HS. Results showed that a higher proportion of patients treated with bimekizumab vs. placebo achieved a 50% or greater improvement in HS signs and symptoms at Week 16, as measured by Hidradenitis Suppurativa Clinical Response (HiSCR)50, the primary endpoint in both trials.

Bimekizumab treatment also resulted in clinically meaningful improvements in the key ranked secondary endpoint, HiSCR75, vs. placebo at Week 16.Clinical responses were sustained to Week 48. The safety profile of bimekizumab was consistent with safety data seen in previous trials across indications with no new safety signals. Detailed results from BE HEARD I and BE HEARD II have been published in The Lancet.

“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 U.S., representing a significant step forward in our mission to alleviate the global burden of immune-mediated inflammatory diseases,” adds Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact and Chief Commercial Officer, UCB. “This progress underscores our commitment to addressing unmet needs in hidradenitis suppurativa and other immunological conditions, delivering innovative medicines, and raising standards of care.”

This FDA approval of bimekizumab for the treatment of adults with moderate-to-severe hidradenitis suppurativa follows its recent approvals for the treatment of adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis. Bimekizumab was first approved in the U.S. in October 2023, for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

HS Experts React

“It is wonderful news that we now have another approved agent for our patients with HS,” Jennifer Hsaio, MD, a Clinical Associate Professor of Dermatology at the University of Southern California in Los Angeles, CA, tells TDD. “Given its robust Phase 3 clinical trial data in HS, bimekizumab is a first-line therapeutic agent to consider for our patients with moderate-to-severe HS, as well as an agent that patients who have had previous biologic exposure can be switched to in hopes of improved efficacy. As clinicians we have witnessed many patients struggle with maintenance of response with their HS medications, so it is exciting to see the deep and durable responses out to week 96 with bimekizumab,” she says,

“HS is a burdensome inflammatory condition with major unmet needs for both patients and health care providers, including a dearth of highly effective, targeted treatment options,” Raj Chovatiya, MD, PhD, Founder and Director of the Center for Medical Dermatology and Immunology Research in Chicago, IL, tells TDD.” The approval of Bimzelx as a first-in-class biologic treatment targeting IL17A and IL17F in patients with moderate-severe HS is an exciting day, as the data supports the ability for patients to achieve and maintain high levels of therapeutic response.”

Access Information

For additional medical information, patient assistance or any other information, please call UCBCares at 1-844-599-CARE (2273) or visit askucbcares.com. Full affordability information can be found at UCB-USA.com/Affordability and www.BIMZELX.com.