UCB Receives U.S. FDA Approval for 320 mg Single-Injection Device Presentations of Bimzelx (bimekizumab-bkzx)
Brussels (Belgium), October 14, 2024 – 07:00 (CEST) – UCB, a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a 2 mL pre-filled syringe and pre-filled autoinjector, each containing 320 mg of Bimzelx ® (bimekizumab-bkzx).
These new device presentations add to the currently available 1 mL administration options, each containing 160 mg of bimekizumab-bkzx, and mean that patients requiring a 320 mg dose of bimekizumab-bkzx will have options for single-injection administration.1
“Our goal with these single-injection regimens is to strengthen and expand administration options, increase convenience and enhance the individual patient experience,” said Emmanuel Caeymaex, Executive Vice President, Head of Patient Impact, Chief Commercial Officer, UCB. “With the new device presentations, people with moderate-to-severe plaque psoriasis who receive a bimekizumab-bkzx maintenance dose of 320 mg will have the option of a single-injection every eight weeks.”
The approval of the 320 mg device presentations is supported by data from studies evaluating the bioequivalence of bimekizumab-bkzx 320 mg given as one 2 mL subcutaneous injection, and bimekizumab-bkzx 320 mg given as two 1 mL subcutaneous injections, in healthy study participants. This is the second worldwide approval for the 320 mg single-injection administration options for bimekizumab-bkzx, following approval by the European Commission in August 2024.2
In the U.S., the indications for bimekizumab-bkzx where a 320 mg dose is recommended are adults with moderate-to-severe plaque psoriasis and adults with active psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis.1* In all other indications, adults with active psoriatic arthritis, adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation, and adults with active ankylosing spondylitis, a 160 mg dose is recommended.1
In October 2023, bimekizumab-bkzx was first approved by the U.S. FDA for the treatment of moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.1 In September 2024, bimekizumab-bkzx was approved in the U.S. for three new indications – 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
These new device presentations will be available in the U.S. in Q1 2025.
*The recommended dosage of bimekizumab-bkzx in patients with plaque psoriasis and patients with psoriatic arthritis with coexistent moderate-to-severe plaque psoriasis is 320 mg at Weeks 0, 4, 8, 12, and 16, then every 8 weeks thereafter. For patients weighing 120 kg or more, consider a dosage of 320 mg every 4 weeks after Week 16.
About Bimzelx ® (bimekizumab-bkzx) in the U.S.
Bimekizumab-bkzx 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
Bimzelx U.S. IMPORTANT SAFETY INFORMATION
Suicidal Ideation and BehaviorBimzelx ® (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 (≥ 1%) adverse reactions in plaque psoriasis 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 infection.
Please see Important Safety Information below and full U.S. Prescribing Information at www.UCB-USA.com/Innovation/Products/Bimzelx .
About Bimzelx ®▼(bimekizumab) in the European Union (EU)/European Economic Area (EEA)
The approved indications for bimekizumab▼ in the EU are:2
The label information may differ in other countries where approved. Please check local prescribing information.
Bimzelx ®▼(bimekizumab) EU/EEA Important Safety Information
The most frequently reported adverse reactions with bimekizumab were upper respiratory tract infections (14.5%, 14.6%, 16.3%, 8.8% in plaque psoriasis, psoriatic arthritis, axial spondyloarthritis (axSpA) and hidradenitis suppurativa, respectively) and oral candidiasis (7.3%, 2.3%, 3.7%, 5.6% in PSO, PsA, axSpA and HS, respectively). Common adverse reactions (≥1/100 to <1/10) were oral candidiasis, tinea infections, ear infections, herpes simplex infections, oropharyngeal candidiasis, gastroenteritis, folliculitis, vulvovaginal mycotic infection (including vulvovaginal candidiasis), headache, rash, dermatitis and eczema, acne, injection site reactions, fatigue. Elderly may be more likely to experience certain adverse reactions such as oral candidiasis, dermatitis and eczema when using bimekizumab.
Bimekizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients and in patients with clinically important active infections (e.g. active tuberculosis).
Bimekizumab may increase the risk of infections. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection. Patients treated with bimekizumab should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops an infection the patient should be carefully monitored. If the infection becomes serious or is not responding to standard therapy, treatment should be discontinued until the infection resolves. Prior to initiating treatment with bimekizumab, patients should be evaluated for tuberculosis (TB) infection. Bimekizumab should not be given in patients with active TB. Patients receiving bimekizumab should be monitored for signs and symptoms of active TB.
Cases of new or exacerbations of inflammatory bowel disease have been reported with bimekizumab. Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, bimekizumab should be discontinued and appropriate medical management should be initiated.
Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.
Live vaccines should not be given in patients treated with bimekizumab.
Please consult the Summary of Product Characteristics in relation to other side effects, full safety and Prescribing Information.European SmPC date of revision: August 2024. https://www.ema.europa.eu/en/documents/product-information/Bimzelx -epar-product-information_en.pdf.
Last accessed: October 2024.
▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.
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: @UCB_news.
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UCB’s efforts to acquire other products or companies and to integrate the operations of such acquired companies may not be as successful as UCB may have believed at the moment of acquisition. Also, UCB or others could discover safety, side effects or manufacturing problems with its products and/or devices after they are marketed. The discovery of significant problems with a product similar to one of UCB’s products that implicate an entire class of products may have a material adverse effect on sales of the entire class of affected products. Moreover, sales may be impacted by international and domestic trends toward managed care and health care cost containment, including pricing pressure, political and public scrutiny, customer and prescriber patterns or practices, and the reimbursement policies imposed by third-party payers as well as legislation affecting biopharmaceutical pricing and reimbursement activities and outcomes. Finally, a breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of UCB’s data and systems. Given these uncertainties, you should not place undue reliance on any of such forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labelling in any market, or at any particular time, nor can there be any guarantee that such products will be or will continue to be commercially successful in the future.UCB is providing this information, including forward-looking statements, only as of the date of this press release. UCB expressly disclaims any duty to update any information contained in this press release, either to confirm the actual results or to report or reflect any change in its forward-looking statements with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless such statement is required pursuant to applicable laws and regulations. Additionally, information contained in this document shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any offer, solicitation or sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such jurisdiction.
References
Source: UCB
Posted : 2024-10-22 18:00
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