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UCB Receives U.S. FDA Approval for BIMZELX® (bimekizumab-bkzx) as the First IL-17A and IL-17F Inhibitor for Adults with Moderate-to-Severe Hidradenitis Suppurativa
Approval is supported by data from the two Phase 3 studies, BE HEARD I and BE HEARD II, in which BIMZELX® (bimekizumab-bkzx) improved the signs and symptoms of disease vs. placebo at Week 16, which were sustained to Week 48
Hidradenitis suppurativa is a chronic, painful, and potentially debilitating inflammatory skin disease
The milestone marks the fifth indication for BIMZELX in the U.S., underscoring UCB's commitment to raising standards of care across a range of IL-17 mediated diseases
ATLANTA, Nov. 20, 2024/PRNewswire/ -- Regulated Information – Inside Information – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of adults with moderate-to-severe hidradenitis suppurativa (HS).1 BIMZELX is the first and only approved medicine designed to selectively inhibit interleukin 17F (IL-17F) in addition to interleukin 17A (IL-17A).1
(PRNewsfoto/UCB, Inc.)
"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," said investigator and lead author of the studies, Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center and Professor of Dermatology, Harvard Medical School, Boston, Massachusetts. "In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks."
Hidradenitis suppurativa is a chronic, recurring, painful, and potentially debilitating inflammatory skin disease.2-3 The main symptoms are nodules, abscesses, and pus-discharging fistulas, i.e., channels leading out of the skin, typically in the armpits, groin, and buttocks.2-3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.2-3
"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," said Brindley Brooks, Founder and Executive Director, HS Connect, U.S.
The approval is supported by data from two Phase 3 studies, BE HEARD I and BE HEARD II, which evaluated the efficacy and safety of BIMZELX in the treatment of adults with moderate-to-severe HS.4 Results showed that a higher proportion of patients treated with BIMZELX vs. placebo achieved a 50 percent or greater improvement in HS signs and symptoms at Week 16, as measured by HiSCR50, the primary endpoint in both trials.4 BIMZELX treatment also resulted in clinically meaningful improvements in the key ranked secondary endpoint, HiSCR75, vs. placebo at Week 16.4 Clinical responses were sustained to Week 48.4 The safety profile of BIMZELX was consistent with safety data seen in previous trials across indications with no new safety signals.4 Detailed results from BE HEARD I and BE HEARD II have been published in The Lancet.4
"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," said 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 BIMZELX 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.1 BIMZELX 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.1
Additional information about BIMZELX, including the full prescribing information, is available at UCB-USA.com/Innovation/Products/BIMZELX. For additional medical information, patient assistance or any other information, please call UCBCares® at 1-844-599-CARE (2273) or visit askucbcares.com. UCB's goal is to enable affordable access to our medicines for all people who need them, in a way which is sustainable for patients, society and UCB. Full affordability information can be found at UCB-USA.com/Affordability and www.BIMZELX.com.
Notes to Editors:
About Hidradenitis Suppurativa Hidradenitis suppurativa (HS) is a chronic, painful, and potentially debilitating inflammatory skin disease that is associated with systemic manifestations.2-3 The main symptoms are nodules, abscesses, and pus-discharging draining tunnels (or sinus tracts leading out of the skin) that typically occur in the armpits, groin, and buttocks.2-3 People with HS experience flare-ups of the disease as well as severe pain, which can have a major impact on quality of life.2-3 HS develops in early adulthood and affects approximately one percent of the population in most studied countries.2-3
About BE HEARD I and BE HEARD II BE HEARD I and BE HEARD II are randomized, double-blind, placebo-controlled, parallel group, multicenter, Phase 3 studies designed to evaluate the efficacy and safety of BIMZELX in adults with moderate-to-severe hidradenitis suppurativa (HS).4 The two studies had a combined enrollment of 1,014 participants with a diagnosis of moderate-to-severe HS.4 The primary endpoint in both studies was HiSCR50 at Week 16.4 Secondary endpoints included HiSCR75 and HS-specific skin pain response at Week 16.1,4 HiSCR50 and HiSCR75 are defined as at least either a 50 or 75 percent reduction from baseline in the total abscess and inflammatory nodule count, with no increase from baseline in abscess or draining tunnel count.4 Detailed results from these studies are published in The Lancet.4
About BIMZELX® (bimekizumab-bkzx) in the U.S. BIMZELX is a humanized IgG1 monoclonal antibody that selectively binds to IL-17A, IL-17F and IL-17AF cytokines, blocking their interaction with the IL-17RA/IL-17RC receptor complex.1
The approved indications for BIMZELX in the U.S. are:1
Plaque psoriasis: BIMZELX is approved for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy
Psoriatic arthritis: BIMZELX is indicated for the treatment of adult patients with active psoriatic arthritis
Non-radiographic axial spondyloarthritis: BIMZELX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis with objective signs of inflammation
Ankylosing spondylitis: BIMZELX is indicated for the treatment of adult patients with active ankylosing spondylitis
Hidradenitis suppurativa: BIMZELX is indicated for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa
Suicidal Ideation and Behavior BIMZELX (bimekizumab-bkzx) may increase the risk of suicidal ideation and behavior (SI/B). A causal association between treatment with BIMZELX and increased risk of SI/B has not been definitively established. Prescribers should weigh the potential risks and benefits before using BIMZELX in patients with a history of severe depression or SI/B. Advise monitoring for the emergence or worsening of depression, suicidal ideation, or other mood changes. If such changes occur, instruct to promptly seek medical attention, refer to a mental health professional as appropriate, and re-evaluate the risks and benefits of continuing treatment.
Infections BIMZELX may increase the risk of infections, including serious infections. Do not initiate treatment with BIMZELX in patients with any clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing BIMZELX. Instruct patients to seek medical advice if signs or symptoms suggestive of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer BIMZELX until the infection resolves.
Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with BIMZELX. Avoid the use of BIMZELX in patients with active TB infection. Initiate treatment of latent TB prior to administering BIMZELX. Consider anti-TB therapy prior to initiation of BIMZELX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Closely monitor patients for signs and symptoms of active TB during and after treatment.
Liver Biochemical Abnormalities Elevated serum transaminases were reported in clinical trials with BIMZELX. Test liver enzymes, alkaline phosphatase, and bilirubin at baseline, periodically during treatment with BIMZELX and according to routine patient management. If treatment-related increases in liver enzymes occur and drug-induced liver injury is suspected, interrupt BIMZELX until a diagnosis of liver injury is excluded. Permanently discontinue use of BIMZELX in patients with causally associated combined elevations of transaminases and bilirubin. Avoid use of BIMZELX in patients with acute liver disease or cirrhosis.
Inflammatory Bowel Disease Cases of inflammatory bowel disease (IBD) have been reported in patients treated with IL-17 inhibitors, including BIMZELX. Avoid use of BIMZELX in patients with active IBD. During BIMZELX treatment, monitor patients for signs and symptoms of IBD and discontinue treatment if new onset or worsening of signs and symptoms occurs.
Immunizations Prior to initiating therapy with BIMZELX, complete all age-appropriate vaccinations according to current immunization guidelines. Avoid the use of live vaccines in patients treated with BIMZELX.
Most Common Adverse Reactions Most common (≥ 1%) adverse reactions in plaque psoriasis and hidradenitis suppurativa include upper respiratory tract infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex infections, acne, folliculitis, other candida infections, and fatigue.
Most common (≥ 2%) adverse reactions in psoriatic arthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, and urinary tract infections.
Most common (≥ 2%) adverse reactions in non-radiographic axial spondyloarthritis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, cough, fatigue, musculoskeletal pain, myalgia, tonsillitis, transaminase increase, and urinary tract infections.
Most common (≥ 2%) adverse reactions in ankylosing spondylitis include upper respiratory tract infections, oral candidiasis, headache, diarrhea, injection site pain, rash, and vulvovaginal mycotic infection.
For further information, contact UCB: Investor Relations Antje Witte T +32.2.559.94.14 email antje.witte@ucb.com
About UCB UCB, Brussels, Belgium (www.ucb.com) is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With approximately 9,000 people in approximately 40 countries, the company generated revenue of €5.3 billion in 2023. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
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Kimball AB, Jemec GBE, Sayed CJ, et al. Efficacy and safety of bimekizumab in patients with moderate-to-severe hidradenitis suppurativa (BE HEARD I and BE HEARD II): two 48 week, randomised, double blind, placebo controlled, multicentre phase 3 trials. Lancet. 2024;403(10443):2504-19.
