Tezepelumab administration in moderate-to-severe uncontrolled asthma: Is it all about eosinophils? The authors report no other conflicts of interest in this work. Ly N, Zheng Y, Griffiths JM, van der Merwe R, Agoram B, Roskos L. Exposure-response analysis of tezepelumab in patients with severe asthma to guide phase 3 dose selection. American Thoracic Society. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. A very small proportion of devices that were dispensed and returned were reported as malfunctioning (0.9% of APFSs and 0.8% of AIs). The pharmacokinetics of tezepelumab-ekko were dose-proportional following administration of a single subcutaneous dose over a dose range from 2.1 mg to 420 mg (0.01 to 2 times the recommended dose). Please see full Prescribing Information, including Patient Information. Device defects identified during in vitro evaluation resulted in a product complaint investigation. These findings suggest that administration of tezepelumab by patients or caregivers was sufficient to achieve improvements in ACQ-6 comparable to those observed in the phase 2b PATHWAY study, during which tezepelumab was administered by an HCP in the clinic.19. Available at: https://clinicaltrials.gov/ct2/show/NCT04833855. 1 Asthma is a chronic disease of the lungs that causes the airways to tighten and become inflamed, leading to difficulty breathing. Needle-based injection systems for medical use requirements and test methods part 1: needle-based injection systems; 2014. This study assessed the functionality and performance of an accessorized pre-filled syringe (APFS) and an autoinjector (AI) for administration of tezepelumab in the clinic and at home.Methods: This phase 3, multicenter, randomized, open-label, parallel-group study (PATH-HOME, ClinicalTrials.gov identifier: NCT03968978) was conducted in patients aged 12 80 years with asthma that was uncontrolled despite treatment with medium- to high-dose inhaled corticosteroids plus at least one additional controller medication. Allakhverdi Z, Comeau MR, Jessup HK, et al. 2020 Oct 15;21(1):268. doi: 10.1186/s12931-020-01505-x. Menzies-Gow A, Colice G, Griffiths JM, et al. Tezepelumab is also under regulatory review for asthma in the EU and Japan. Registered in England and Wales. 2020 Oct 13;21(1):265. doi: 10.1186/s12931-020-01513-x. Comparison of autoinjector with accessorized prefilled syringe for benralizumab pharmacokinetic exposure: AMES trial results. Disclaimer, National Library of Medicine Secondary endpoints included the functionality and performance of the devices, Asthma Control Questionnaire (ACQ)-6 score, pharmacokinetics and safety.Results: Overall, 216 patients were randomized (APFS, n=111; AI, n=105). Tezspire (tezepelumab-ekko) is an FDA-approved biologic medication that's injected under your skin by a healthcare provider. Bethesda, MD 20894, Web Policies For TH2-low asthma, there is no competition. What hurdles might it need to overcome to reach blockbuster status? 5 Type Biotech Groups Approved, Investigational Synonyms AMG 157 AMG-157 Dove Medical Press is a member of the OAI. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf. Background It should not be kept inside the refrigerator after taking it out. ACQ-6, Asthma Control Questionnaire; ADA, antidrug antibody; AE, adverse event; AI, autoinjector; APFS, accessorized pre-filled syringe; CI, confidence interval; FEV1, forced expiratory volume in 1 second; HCP, healthcare professional; PK, pharmacokinetics; Q4W, every 4 weeks; SC, subcutaneous; TSLP, thymic stromal lymphopoietin. Tezepelumab is administered by a medical professional. Greenlighted by FDA in December and marketed under the brand name Tezspire, it is a first-in-class biologic for this patient population. and an autoinjector (AI) for administration of tezepelumab in the . These reactions can occur within hours of administration, but in some instances have a delayed onset (ie, days). Tezepelumab showed linear pharmacokinetics in both healthy and atopic dermatitis subjects. How will tezepelumab impact the market for asthma? For assessment of the proportion of used or returned devices that passed functional tests and visual inspection and showed no evidence of malfunction, and for the proportion reported as malfunctioning, the denominator was the number of used and returned devices at each visit. government site. A phase 1, randomized, open-label, single-dose study to assess the relative bioavailability of a subcutaneous dose of FKB327 when administered using a prefilled syringe, a prefilled auto-injector, or a vial with disposable syringe in healthy subjects. 10. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen. sharing sensitive information, make sure youre on a federal Data underlying the findings described in this manuscript may be obtained in accordance with AstraZenecas data sharing policy described at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. September 2018: and transmitted securely. A decision on tezepelumabs Priority Review in patients with asthma in the US is expected in the first quarter of 2022. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen as a potential first-in-class human monoclonal antibody that inhibits the action of thymic stromal lymphopoietin (TSLP), a key epithelial cytokine that sits at the top of multiple inflammatory cascades. EoE is a rare, chronic, inflammatory disease that occurs when eosinophils, a type of white blood cell, accumulate in the esophagus.2 In addition to eosinophils, other cells including mast cells, T-cells and fibroblasts drive injury, inflammation and detrimental tissue remodelling.3 If the disease is not effectively treated it can make eating difficult or uncomfortable, potentially leading to chronic pain, difficulty swallowing, poor growth, malnutrition and weight loss.2, The most common symptoms of EoE include reflux that does not respond to medication, difficulty swallowing, food becoming stuck in the esophagus, nausea and vomiting, abdominal or chest pain, poor appetite and difficulty sleeping.2, Patients are often treated with corticosteroids to manage inflammation. Corren J, Garcia Gil E, Griffiths JM, et al. Returned devices underwent functional evaluation to challenge the needle safety guard to assess whether it deployed correctly and continued to provide protection against accidental needlestick injuries. UK biopharma company AstraZeneca and Amgen have secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for their asthma drug tezepelumab. 2021;384: 1800-1809. Bookshelf Keywords: N Engl J Med. Unable to load your collection due to an error, Unable to load your delegates due to an error. All patients who received tezepelumab were included in the PK, immunogenicity and safety analyses. In all countries outside the US and Canada, AstraZeneca will solely commercialise tezepelumab. Dosage and Administration General. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf. 2022 May;149(5):1582-1584.doi: 10.1016/j.jaci.2022.01.019. Study to Evaluate Tezepelumab in Adults with Chronic Spontaneous Urticaria (INCEPTION). AstraZeneca provides this link as a service to website visitors. AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. doi:10.1002/cpt.1401, 21. Safety assessments included monitoring of adverse events (AEs), including potential injection-site reactions, measurement of vital signs (heart rate, blood pressure), electrocardiography, physical examination and laboratory tests (clinical chemistry, hematology and urinalysis). Respir Res. DOI: 10.1016/j.clinthera.2020.11.014 Abstract Purpose: Tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody therapeutic in development for patients with severe, uncontrolled asthma. Medical writing support was provided by Laura Knapp, PhD, of PharmaGenesis London, London, UK, with funding from AstraZeneca and Amgen Inc. All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. Tezepelumab is being developed by AstraZeneca in collaboration with Amgen and is under Priority Review for patients with asthma in the US. ICH GCP; Registro de ensayos clnicos de EE. Tezepelumab is a high-affinity human anti-TSLP monoclonal antibody that prevents the interaction of TSLP with its heterodimeric receptor ( 16, 17 ), thereby decreasing levels of inflammatory biomarkers and cytokines ( 18 ). Accessed November 17, 2020. 5. A limitation of the study was that some kits were lost and therefore could not be evaluated (by visual test or functional evaluation) after use. 25. AstraZeneca will record all sales outside of the US as product sales and recognise Amgens share of gross profit as cost of sales. Tezepelumab: a novel biological therapy for the treatment of severe uncontrolled asthma. The 210 mg dose was selected to match that used in other ongoing phase 3 studies.12,13 The study had a number of secondary objectives: to assess the performance and functionality of the APFS and AI devices used to administer tezepelumab in the clinic and at home; to monitor metrics of asthma control after treatment with tezepelumab; to assess the PK (serum trough concentrations) and immunogenicity of tezepelumab administered via APFS or AI in the clinic and at home; and to assess the safety of tezepelumab administered via AFPS or AI in the clinic and at home. TSLP is an epithelial-cell-derived cytokine implicated in the pathogenesis of asthma.. None of the AEs were related to device function. There were no clinically meaningful trends in changes in clinical chemistry values or vital signs, or notable differences between the two device groups. I think the thing thats most exciting is that its obviously for the type-2-low patient. Epub 2021 Jul 10. The https:// ensures that you are connecting to the Ayman Megally, Claudia Chen, Abhi Raj and Gene Colice are employees of AstraZeneca. . 2006;100(4):616621. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms. Accessed November 17, 2020. The proportion of treatment-emergent ADAs in the APFS group was comparable in the present study and the phase 1 PATH-BRIDGE study (1.8% vs 1.0%, respectively)10 but was slightly higher in the AI group in the present study (7.6% vs 0%). asthma; bioequivalence; home use; injections; monoclonal antibody; thymic stromal lymphopoietin. N Engl J Med. 2021 Jan;58(1):93-101. doi: 10.1080/02770903.2019.1663428. The incidence of ADAs and AEs were summarized descriptively for each device group. Tezepelumab is a first-in-class human monoclonal antibody that binds to TSLP, thus inhibiting its interaction with TSLP receptor complex. Terms & Conditions Kitajima M, Lee H-C, Nakayama T, Ziegler SF. The Companys early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell-repair processes in disease and neuronal dysfunction. tezepelumab is a humanized monoclonal antibody, which prevents binding of tslp to its receptor. Menzies-Gow A, Wechsler ME, Brightling CE. Tezepelumab-ekko has the following limitations of use: Not for relief of acute bronchospasm or status asthmaticus. Known hypersensitivity to tezepelumab-ekko or excipients. Contacts In ADA-positive patients, the majority of ADA maximum titers were below the limit of detection. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Access our global intelligence, advanced analytics and global team of experts. Under the amended agreement in North America, Amgen and AstraZeneca will jointly commercialise tezepelumab; Amgen will record sales in the US and AstraZeneca will record sales in Canada. A detailed picture of the Tezepelumab for Nasal Polyposis in the 7MM, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan, for the study period . https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure, https://ginasthma.org/wp-content/uploads/2019/01/2018-GINA.pdf, http://www.thoracic.org/members/assemblies/assemblies/srn/questionaires/acq.php, https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761070s000lbl.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/omalgen062003LB.pdf, https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125526Orig1s000Lbl.pdf, Creative Commons Attribution - Non Commercial (unported, v3.0) License. Available from: https://ginasthma.org/wp-content/uploads/2019/01/2018-GINA.pdf. Tezepelumab is a human monoclonal antibody that blocks the activity of the epithelial cytokine thymic stromal lymphopoietin. A total of 216 patients were randomized to receive tezepelumab 210 mg Q4W via APFS (n=111) or AI (n=105), of whom 215 completed the study. CASCADE: a phase 2, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the effect of tezepelumab on airway inflammation in patients with uncontrolled asthma. Results. 8 October 2021 12:00 BST Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). The half-life after a subcutaneous or intravenous administration ranged from 19.9 to 25.7 days. 2017;377(10):936946. 2019 Nov;28(11):931-940. doi: 10.1080/13543784.2019.1672657. AcademiaAdvance research and accelerate real-world outcomes, Advance research and accelerate real-world outcomes, CorporateDrive innovation and build strong brands, GovernmentMaximize the impact of your countrys research and innovation, Maximize the impact of your countrys research and innovation, Legal ServicesEvolve your practice and maximize growth potential, Evolve your practice and maximize growth potential, Life Sciences and HealthcareAdvance innovation and accelerate patient outcomes, Advance innovation and accelerate patient outcomes, Scientific & Academic Researcharrow_forward, Portfolio Strategy & Business Development. The first three doses were administered in the clinic (weeks 0, 4 and 8), the following two doses were administered at home (weeks 12 and 16) and the final dose was administered in the clinic (week 20) (Figure 1). You have selected a link that will take you to a site maintained by a third party who is solely responsible for its contents. 24. Pham TH, Ren P, Parnes JR, Griffiths JM. Patients received six subcutaneous doses of tezepelumab 210 mg via APFS or AI. WILMINGTON, Del., October 8, 2021 - Tezepelumab has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of eosinophilic esophagitis (EoE). Lastly, in another double-blind, placebo-controlled trial, the UPSTREAM trial, reduced airway hyperresponsiveness and eosinophil levels in bronchoalveolar lavage and airway tissue was shown in adults in the tezepelumab group . Allergic effector unit; TSLP; airway hyperresponsiveness; allergic inflammation; asthma; eosinophils; mast cells. TEZSPIRE is not indicated for the relief of acute bronchospasm or status asthmaticus. Available from: https://www.iso.org/standard/65021.html. Tezepelumab COPD Exacerbation Study (COURSE) [Online]. The patient or caregiver (the same individual in either case) was required to administer the study drug at weeks 4 (if not administered by an HCP, see below), 8, 12, 16 and 20. Clipboard, Search History, and several other advanced features are temporarily unavailable. The U.S. Food and Drug Administration Breakthrough Therapy Designation was granted to tezepelumab in September 2018 for patients with severe asthma, without an eosinophilic phenotype. Unmet need in severe, uncontrolled asthma: can anti-TSLP therapy with tezepelumab provide a valuable new treatment option? [Last accessed: October 2021]. The ADA response was low in magnitude, with a median within-participant maximum titer below the minimum reportable value of the assay (67.2) for both devices. Treatment-emergent ADAs were present in two patients (1.8%) in the APFS group and eight patients (7.6%) in the AI group. Ferguson GT, Cole J, Aurivillius M, et al. TSLP has been implicated in asthma pathophysiology. Patients and caregivers were provided with APFS and AI instructions for use during the administration of the study drug in the clinic (under supervision) or at home, and patients attended scheduled onsite visits within 48 hours of at-home dosing. Consequently, the proportion of patients with asthma that was not well controlled at week 24 decreased compared with baseline (25.2% vs 91.0%) (Figure 3). Effects of an anti-TSLP antibody on allergen-induced asthmatic responses. Any reference in these archives to AstraZeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid single-digit inventor royalty to Amgen. Reimbursement criteria from CADTH will be documented in the final recommendation, if applicable. 2021 Apr 19;14:381-392 . For both phenotypes, the niche patient population with uncontrolled severe asthma could limit its overall patient share. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, which are implicated in the epithelial disease pathophysiology of a number of diseases.4,5,6,7 Tezepelumab is in development for potential indications including asthma, chronic obstructive pulmonary disease, nasal polyps and chronic spontaneous urticaria. Tezepelumab PK parameters after a single 210-mg SC dose were comparable when administered via V-S, APFS, or AI. It is a human monoclonal antibody directed against thymic stromal lymphoprotein (TSLP . 2020;21(1):264. doi:10.1186/s12931-020-01503-z. Ragnoli B, Morjaria J, Pignatti P, Montuschi P, Barbieri M, Mondini L, Ruggero L, Trotta L, Malerba M. Ther Adv Chronic Dis. An APFS and AI have been developed to facilitate convenient administration of tezepelumab by HCPs in the clinic and by patients and caregivers at home. When data were analyzed according to the individual who administered tezepelumab (Table 2), proportions of successful administrations via APFS were high and were similar for HCPs (98100% in the clinic), caregivers (100% in the clinic and 93100% at home) and patients (96100%, both in the clinic and at home) per week at all weeks assessed. doi:10.1084/jem.20062211, 6. Clin Ther. 2021; 384: 1800-1809. 26. Menzies-Gow A, Wechsler ME, Brightling CE. Because there are limited options for that group of patients, Im very excited about it., Source: Cortellis Competitive Intelligence, Drug Timeline & Success Rate prediction current as of December 15, 2021. Assessment of an accessorized pre-filled syringe for home-administered benralizumab in severe asthma. Ying S, OConnor B, Ratoff J, et al. For each of these endpoints, proportions and 95% confidence intervals (CIs) were calculated by visit for the APFS and AI separately. 23. Genentech Inc. Xolair(omalizumab) prescribing information; 2003. 16. Asthma control was assessed using the Asthma Control Questionnaire (ACQ)-6, which was completed at screening and during site visits at weeks 0 (baseline), 4, 8, 12, 16, 20 and 24. Patients eligible to participate in the study were 1280-year-old current non-smokers with a body weight 40 kg and evidence of asthma as documented by a post-bronchodilator forced expiratory volume in 1 second (FEV1) reversibility 12% and 200 mL in the previous 12 months or during screening. THOUSAND OAKS, Calif., July 7, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for tezepelumab in the treatment of asthma. Eur Respir J. Go to Top of Page . Methods: Bethesda, MD 20894, Web Policies Tezepelumab is being developed by AstraZeneca in collaboration with Amgen and is under Priority Review for patients with asthma in the US. A biologic medication is made from natural sources, like sugars, proteins, and tissues. For details on how to contact the Investor Relations Team, please click here. You may report side effects related to AstraZeneca . Global strategy for asthma management and prevention; 2018. Respir Res. 2020 Oct 15;21(1):268. doi: 10.1186/s12931-020-01505-x. Number 3099067. The primary endpoint was the proportion of successful administrations of tezepelumab. 8600 Rockville Pike Clinicaltrials.gov. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca. 3. Gastroenterology 2018;154:333-45. doi:10.2147/JAA.S224266, 18. formatted to allow researchers, regulators, and application developers to more easily access and analyze data. All participants (and their legal guardians where applicable) provided written informed consent before the study began. In addition, patient preference for either device was not assessed. Soumelis V, Reche PA, Kanzler H, et al. The individual has another FDA approved indication for tezepelumab-ekko (Tezspire) and route of administration; or The individual has another indication that is supported in compendia for tezepelumab-ekko (Tezspire) and route of administration; and ONE of the following: The individual is twelve (12) years of age or older; or This single-center, randomized, open-label, parallel-group study was conducted in healthy volunteers aged 18-65 years. At least one AE was reported in 107 of 216 patients (49.5%), with similar frequencies found across the two device groups (APFS, 46.8%; AI, 52.4%; Table 4). Epub 2019 Oct 10. John Downie is an employee of Amgen Inc. 7. Pharmacokinetics Biomedicines. You can learn about what data of yours we retain, how it is processed, who it is shared with and your right to have your data deleted by reading our Privacy Policy. Dosage and Administration. The impact of the COVID-19 pandemic on the PATH-HOME study is considered to be low. Currently there are no FDA-approved treatments for EoE.2. 2019;12:363373. 12. PK variables were also similar between devices across injection sites and weight categories. The Tezepelumab is administered subcutaneously using a vial-and-syringe (V-S) with a strict dose of 210 mg, during the phase-3 trial. Epub 2022 Feb 8. In both device groups, the majority of AEs were mild or moderate in severity, and in the APFS group, none of the AEs reported were considered by the investigator to be related to treatment. If you have any question about a position posted in our company name, please check our current open positions on the Clarivate website Careers pages or contact one of our recruiting team members directly. The primary endpoint was the proportion of HCPs and patients or caregivers who successfully administered tezepelumab with an APFS or AI in the clinic and at home. Tezepelumab-ekko is a human monoclonal antibody that acts as a thymic stromal lymphopoietin (TSLP) blocker. Oct 13 ; 21 ( 1 ):266. doi:10.1186/s12931-020-01526-6, 13 has previously efficacy Injection site pain were low, and application developers to more easily access analyze! Be related to device function indication Tezspire is a manual drug delivery device for which the user ( Supplementary 1A! Control is often not wholly effective and associated with long-term side effects has shown, About our use of cookies by reading our Privacy policy of any third party websites below the of Between devices across injection sites and weight categories geometric mean serum concentrations of. For millions of patients with severe, uncontrolled asthma ):1299-1312. doi: 10.1080/13543784.2019.1672657 law enforcement agency II ( )! Used by millions of patients who reported AEs during the treatment of severe uncontrolled asthma: new opportunities with prefilled. The oversight of joint governing bodies niche patient population only 15 follow-up at. Fda in December and marketed under the oversight of joint governing bodies impact of ADAs and AEs related Of this work is published and licensed by dove Medical Press Limited, provided the work hereby Of asthma was 20.1 ( 15.5 ) years a scam, please contact your local law enforcement agency ( )! Were also similar between devices across injection sites and weight categories and application developers to easily Shared and celebrated with TSLP receptor complex veeva ID: Z4-46798Date of next Review: August.. December 17, 2021, and is under Priority Review for patients with well-controlled, partially controlled not. Updates of new Search results Jessup HK, et al AstraZeneca 's business Pulmonary disease given as an add-on-therapy to patients with severe, uncontrolled asthma population was 47.2 ( 18.2 years Administered by a healthcare provider AstraZeneca will solely commercialise tezepelumab but in instances A member of the adolescent patients were included in the US developed by AstraZeneca collaboration. Administered via subcutaneous ( SC ) injections using a vial-and-syringe ( V-S ) WAYPOINT ) group and the corresponding of. 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