BIMZELX® Approved by the U.S. FDA for the Treatment of Adults with Moderate-to-Severe Plaque Psoriasis
BIMZELX® (bimekizumab-bkzx) is the first and only IL-17A and IL-17F inhibitor approved for the treatment of adults with moderate-to-severe plaque psoriasis
Approval is supported by three Phase 3 trials where bimekizumab consistently delivered fast, complete and lasting levels of skin clearance up to one year, and was generally well tolerated
UCB expects global peak sales for BIMZELX of at least €4 billion
ATLANTA, Oct. 18, 2023 /PRNewswire/ -- Regulated Information – Inside Information – UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1 BIMZELX is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).1 The approval of BIMZELX is supported by data from three Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials (BE READY, BE VIVID, and BE SURE), which evaluated the efficacy and safety of BIMZELX in 1,480 adults with moderate-to-severe plaque psoriasis.2,3,4
"Today's FDA approval for BIMZELX is an exciting milestone that reflects our commitment to continuously improving the standard of care in plaque psoriasis and to raising expectations of what treatment can deliver. We know that completely clear skin is valued by people with psoriasis and, in our Phase 3 trials, at week 16, 85-91% of patients treated with BIMZELX achieved clear or almost clear skin, with 59-68% achieving the goal of complete clearance," said Emmanuel Caeymaex, Executive Vice President, Immunology Solutions and Head of U.S., UCB. "With BIMZELX now approved for psoriasis, we will move forward rapidly to submit applications for additional indications in the U.S."
"We have been eagerly awaiting bimekizumab, the first IL-17A and IL-17F inhibitor, to be approved in the U.S. for the treatment of adults with moderate-to-severe plaque psoriasis. In Phase 3/3b trials, bimekizumab achieved superior levels of skin clearance at week 16 compared to placebo and three existing biologics for psoriasis, with responses being rapid and lasting up to a year. Long-term data have also shown that the majority of patients maintained high levels of clinical response through three years," said Mark Lebwohl, MD, bimekizumab investigator, Dean for Clinical Therapeutics, Icahn School of Medicine at Mount Sinai, and Chairman Emeritus, Kimberly and Eric J. Waldman Department of Dermatology.
Psoriasis affects more than 7.5 million adults in the U.S. and impacts much more than the skin itself.5 In addition to the recognized skin symptoms such as itching and flaking, psoriasis can place strains on patients and their families, impacting work, relationships and home lives.6,7 A U.S. observational study (n=846) reported that only one in four patients achieved self-assessed complete skin clearance after six months of treatment with biologics highlighting the burden of plaque psoriasis and the need for additional new treatment options.8
The FDA recommended dosage of BIMZELX for psoriasis patients is 320 mg (given as two subcutaneous injections of 160 mg each) at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter.1 For patients weighing ≥120 kg, a dose of 320 mg every 4 weeks after week 16 may be considered.1 BIMZELX may be administered by a healthcare professional, or a patient may self-inject after proper training.1 BIMZELX is available as an autoinjector and a pre-filled syringe.1 BIMZELX will be available in the U.S. in approximately one month.
"The approval of bimekizumab will provide an important new treatment option for adults living with moderate-to-severe plaque psoriasis," said Leah McCormick Howard, J.D., President and CEO for the National Psoriasis Foundation. "Our hope is that new treatments translate into improved outcomes for many and help alleviate the physical and emotional burden of psoriasis."
Jean-Christophe Tellier, CEO, UCB added, "We are pleased to deliver new options for people living with severe diseases as part of an unprecedented series of product launches from UCB around the world. Delivering these solutions draws on our scientific expertise and understanding of disease biology and our legacy of deep understanding of patients to provide differentiated treatments. Our continued work embodies what UCB stands for – that we are inspired by patients, driven by science."
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/Sustainability/Affordability/Bimzelx-Pricing-Info and http://www.BIMZELX.com.
Key Findings from the Phase 3 Clinical Development Program
The efficacy and safety of BIMZELX were evaluated in three Phase 3 studies, versus placebo and ustekinumab (BE VIVID), versus placebo (BE READY), and versus adalimumab (BE SURE). 2,3,4 All studies met their co-primary endpoints and all ranked secondary endpoints.2,3,4
Patients treated with BIMZELX achieved superior levels of skin clearance at week 16, compared to those who received ustekinumab (ranked secondary endpoint, BE VIVID; p<0.0001), placebo (co-primary endpoint, BE READY and BE VIVID; p<0.0001) and adalimumab (co-primary endpoint, BE SURE; p<0.001), as measured by at least a 90 percent improvement in the Psoriasis Area & Severity Index (PASI 90) and an Investigator's Global Assessment (IGA) response of clear or almost clear skin (IGA 0/1).2,3,4 Ranked secondary endpoints included PASI 75 at week 4 and PASI 100 (complete skin clearance) at week 16.2,3,4 Key findings across all studies include:
Clear or Almost Clear Skin: More than eight out of 10 patients receiving BIMZELX (320 mg every four weeks [Q4W]) achieved PASI 90 and IGA 0/1 at week 16.2,3,4
Complete Skin Clearance: Approximately six out of 10 patients receiving BIMZELX (320 mg Q4W) achieved PASI 100 at week 16.2,3,4
Speed of Response: Clinical responses achieved with BIMZELX were rapid, with more than seven out of 10 patients achieving PASI 75 at week 4 following one dose (320 mg).2,3,4
Maintenance of Response: Clinical responses achieved with BIMZELX at week 16 (PASI 90 and PASI 100) were maintained for up to one year.2,3,4 Long-term data showed that clinical responses were maintained in the vast majority of patients through to three years of BIMZELX treatment.9
The most common adverse reactions (≥ 1%) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.1
Notes to Editors:
Dr. Lebwohl is an investigator for UCB. He has not accepted any consulting payments from UCB.
About BIMZELX (bimekizumab-bkzx)
Bimekizumab 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 Elevated levels of IL-17A and IL-17F are found in lesional psoriatic skin.1
Please see Important Safety Information below and full U.S. prescribing information at UCB-USA.com/Innovation/Products/BIMZELX and http://www.BIMZELX.com.
BIMZELX U.S. IMPORTANT SAFETY INFORMATION
IMPORTANT SAFETY INFORMATION
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 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, advise 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. 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 adverse reactions (≥ 1%) are upper respiratory infections, oral candidiasis, headache, injection site reactions, tinea infections, gastroenteritis, Herpes Simplex Infections, acne, folliculitis, other Candida infections, and fatigue.
For further information, contact UCB:
Investor Relations
Antje Witte
T +32.2.559.94.14
email antje.witte@ucb.com
U.S. Communications
Ally Funk
T +1.678.365.6321
email ally.funk@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 8,700 people in approximately 40 countries, the company generated revenue of €5.5 billion in 2022. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on Twitter: @UCBUSA.
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References
BIMZELX (bimekizumab) U.S. Prescribing Information https://www.ucb-usa.com/Innovation/Products/Bimzelx. Last accessed: October 2023.
Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate-to-severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487–498.
Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate-to-severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475–486.
Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in plaque psoriasis. N Engl J Med. 2021;385(2):130–141.
National Psoriasis Foundation. About Psoriasis webpage. Available at: https://www.psoriasis.org/about-psoriasis/Last accessed: October 2023.
Armstrong AW, Schupp C, Wu J, et al. Quality of life and work productivity impairment among psoriasis patients: findings from the National Psoriasis Foundation survey data 2003-2011. PLoS One. 2012;7:e52935.
Eghlileb AM, Davies EEG, Finlay AY. Psoriasis has a major secondary impact on the lives of family members and partners. Br J Dermatol. 2007;156(6):1245–1250.
Seneschal J, Lacour J-P, Bewley A et al. A multinational, prospective, observational study to estimate complete skin clearance in patients with moderate-to-severe plaque PSOriasis treated with BIOlogics in a REAL world setting (PSO-BIO-REAL). J Eur Acad Dermatol Venereol. 2020 Nov;34(11):2566-2573.
Strober B, Tada Y, Mrowietz U et al. Bimekizumab maintenance of response through three years in patients with moderate to severe plaque psoriasis who responded at Week 16: Results from the BE BRIGHT open-label extension trial. Br J Dermatol. 2023; 24;188(6):749-759.
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