First and only biologic approved in the EU in patients with severe asthma with no phenotype or biomarker limitations
AstraZeneca’s Tezspire( tezepelumab) has been approved in the European Union( EU) as an add- on conservation treatment in cases 12 times and aged with severe asthma who are deficiently controlled with high cure gobbled corticosteroids plus another medicinal product.
The blessing by the European Commission was grounded on results from the PATHFINDER clinical trial programme, which included the vital NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and crucial secondary endpoint in cases with severe asthma, compared to placebo, when added to standard remedy.1 The blessing follows the recommendation by The Committee for Medicinal Products for Human Use( CHMP) of the European Medicines Agency in July 2022.
Tezspire is the first and only birth approved in Europe for severe asthma that acts at the top of the seditious waterfall by blocking thymic stromal lymphopoietin( TSLP), an epithelialcytokine.1- 4 Tezspire constantly and significantly reduced asthma exacerbations across the PATHWAY Phase II and the NAVIGATOR Phase III clinical trials, which included a broad population of severe asthma cases irrespective of crucial biomarkers, including blood eosinophil counts, antipathetic status and fractional exhaled nitric oxide( FeNO).1, 2
Tezspire( tezepelumab) is being developed by AstraZeneca in collaboration with Amgen as a first- in- class mortal monoclonal antibody that inhibits the action of TSLP, a crucial epithelial cytokine that sits at the top of multiple seditious falls and is critical in the inauguration and continuity of antipathetic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.2, 3 TSLP is released in response to multiple triggers associated with asthma exacerbations, including allergens, contagions and other airborne patches.2, 3 Expression of TSLP is increased in the airways of cases with asthma and has been identified with complaint inflexibility.2, 4 Blocking TSLP may help the release ofpro-inflammatory cytokines by vulnerable cells, performing in the forestallment of asthma exacerbations and bettered asthma control.1,,4 Tezspire acts at the top of the inflammation waterfall and has the implicit to help address a broad population of severe asthma cases irrespective of biomarker situations.1, 2
Tezspire is approved in the US for the add- on conservation treatment of adult and paediatric cases progressed 12 times and aged with severe asthma.5 Tezspire is also in development for other implicit suggestions including habitual obstructive pulmonary complaint( COPD), habitual rhinosinusitis with nasal cysts, habitual robotic urticaria and eosinophilic esophagitis( EoE). In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE.
In 2020, Amgen and AstraZeneca streamlined a 2012 collaboration agreement for Tezspire. Both companies will continue to partake costs and gains inversely after payment by AstraZeneca of a medial single- number innovator kingliness to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. All aspects of the collaboration are under the oversight of common governing bodies. Under the amended agreement, Amgen and AstraZeneca will concertedly commercialise Tezspire in North America. Amgen will record product deals in the US, with AZ recording its share of US gains as Collaboration profit. Outside of the US, AstraZeneca will record product deals, with Amgen recording profit share as Other/ Collaboration profit.
AstraZeneca in Respiratory & Immunology
Respiratory & Immunology, part of BioPharmaceuticals, is one of AstraZeneca’s main complaint areas and is a crucial growth motorist for the Company.
AstraZeneca is an established leader in respiratory care with a 50- time heritage. The Company aims to transfigure the treatment of asthma and COPD by fastening on earlier biology- led treatment, barring preventable asthma attacks, and removing COPD as a top- three leading cause of death. The Company’s early respiratory exploration is concentrated on arising wisdom involving vulnerable mechanisms, lung damage and abnormal cell- form processes in complaint and neuronal dysfunction.
With common pathways and underpinning complaint motorists across respiratory and immunology, AstraZeneca is following the wisdom from habitual lung conditions to immunology- driven complaint areas. The Company’s growing presence in immunology is concentrated on five medial- to late- stage votes withmulti-disease eventuality, in areas including rheumatology( including systemic lupus erythematosus), dermatology, gastroenterology, and systemic eosinophilic- driven conditions. AstraZeneca’s ambition in Respiratory & Immunology is to achieve complaint revision and durable absolution for millions of cases worldwide.
AstraZeneca( LSE/ STO/ Nasdaq AZN) is a global, wisdom- led biopharmaceutical company that focuses on the discovery, development, and commercialisation of tradition drugs in Oncology, Rare conditions, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Grounded in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative drugs are used by millions of cases worldwide.