AstraZeneca’s aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.The Company is building on a 40-year heritage in respiratory disease and AstraZeneca’s capability in inhalation technology spans both pMDIs and dry powder inhalers, as well as the innovative Co-SuspensionMedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. These findings highlight the potential advantages of targeting an upstream cytokine such as TSLP, which may affect disease activity more broadly than inhibition of a single downstream pathway.
MedImmune is pioneering innovative research and exploring novel pathways across Respiratory & Autoimmunity, Cardiovascular & Metabolic Diseases, Oncology, and Infection and Vaccines.
Randomization was stratified according to location (Japan or the rest of the world), blood eosinophil count (≥250 or <250 cells per microliter) as measured by a local laboratory, and dose level of inhaled glucocorticoids (medium or high, on the basis of GINA 2012 guidelinesPatients were assigned to receive subcutaneous injections of tezepelumab at a dose of 70 mg every 4 weeks (low dose), 210 mg every 4 weeks (medium dose), or 280 mg every 2 weeks (high dose) or of placebo every 2 weeks for the duration of the trial.
AstraZeneca and Amgen Inc. (Amgen) announce results from the PATHWAY Phase IIb trial of tezepelumab that showed a significant reduction in the annual asthma exacerbation rate compared with placebo in patients with severe, uncontrolled asthma. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.This website is intended for people seeking information on AstraZeneca's worldwide business.
Similar results were observed in patients regardless of blood eosinophil counts at enrollment.
Sep 2, 2020
All the authors vouch for the accuracy and completeness of the data and the statistical analysis and for the adherence of the trial to the final This trial was performed in accordance with the ethical principles of the Declaration of Helsinki, International Conference on Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements. Sep 1, 2020
The results were published in the The PATHWAY trial was a Phase IIb 52-week, randomised, double-blind, parallel group, placebo-controlled trial designed to evaluate the efficacy and safety of three dose regimens of tezepelumab, 70mg and 210mg every four weeks and 280mg every two weeks, as an add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma receiving inhaled corticosteroids/long-acting beta-agonist with or without oral corticosteroids and additional asthma controllers.Respiratory disease is one of AstraZeneca’s main therapy areas, and the Company has a growing portfolio of medicines that reached more than 18 million patients in 2016. A new kind of injectable biotech treatment for severe asthma from AstraZeneca and Amgen promises to help a much broader range of patients than existing medicines like GlaxoSmithKline’s Nucala. The sponsors, MedImmune and Amgen, devel - oped the protocol and conducted the data analy - sis. No other potential conflict of interest relevant to this article was reported.This article was updated on April 18, 2019, at NEJM.org.We thank Sarah Crouch, Dewei She, Bing Yao, Yili Pritchett, and Matthew Butler for contributions to trial design and analysis and Rachel Cicchelli, Ph.D. (QXV Comms [Macclesfield, United Kingdom], an Ashfield Company, part of UDG Healthcare), who provided medical writing support funded by MedImmune in accordance with the third edition of the Good Publication Practice (GPP3) guidelines (From the David Geffen School of Medicine at the University of California, Los Angeles, Los Angeles (J.C.), and Amgen, Thousand Oaks (J.R.P., M.M.)
Of the patients who received tezepelumab or placebo and were included in the intention-to-treat population, 364 (88.3%) and 130 (94.2%) completed the trial regimen, respectively (Fig. No adjustments were made for multiplicity for the secondary end points.
By binding to TSLP, tezepelumab impacts multiple downstream inflammatory pathways associated with asthma, as shown by striking reductions in the level of multiple biomarkers in the PATHWAY trial, including blood eosinophils, IgE and FeNO.