The FDA granted breakthrough designation for AstraZeneca and partner Amgen’s severe asthma treatment, tezepelumab, marking AstraZeneca’s first breakthrough designation in respiratory medicine.The treatment is for patients without an eosinophilic phenotype that are receiving inhaled corticosteroids/long acting beta2-agonists with or without corticosteroids and additional asthma controllers.The agency’s decision to grant the drug an expedited review was based on Phase IIb Pathway data, which showed a notable reduction in the annual asthma exacerbation rate compared to placebo in a large population of severe asthma patients. T2 inflammation-driven asthma, which includes the eosinophilic phenotype, is present in over two-thirds of patients with severe asthma and is typically characterised by elevated levels of T2 inflammatory biomarkers, including blood eosinophils, serum IgE and fractional exhaled nitric oxide (FeNO). Terms and conditions relating to the use and distribution of this information may apply. By continuing to browse the site you are agreeing to our use of cookies in accordance with our *A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient: Obtains access to the information in a personal capacity; Tezepelumab is a potential first-in-class drug that blocks thymic stromal lymphopoietin (TSLP), an upstream modulator of multiple inflammatory pathways, according to Amgen. A description of FDA expedited ... to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. Tezepelumab granted Breakthrough Therapy Designation by US FDA Fri, Sep 07, 2018 08:00 CET . Dupixent (dupilumab) is an interleukin-4 receptor alpha antagonist indicated: for the treatment of patients aged 6 years and older …
The drug is currently in Phase III clinical trials.300 N. Washington St., Suite 200, Falls Church, VA 22046, USAPhone 703.538.7600 – Fax 703.538.7676 – Toll free 888.838.5578Copyright © 2020. The programme includes additional planned mechanistic and long-term safety trials.NAVIGATOR is a Phase III multicentre, randomised, double-blinded, parallel-group, placebo-controlled trial designed to evaluate the efficacy and safety of a regular, subcutaneous administration of tezepelumab for 52 weeks in adult and adolescent patients with severe asthma inadequately controlled despite treatment with inhaled corticosteroid (ICS) plus one additional asthma controller medication.SOURCE is a Phase III multicentre, randomised, double-blinded, parallel-group, placebo-controlled trial for 48 weeks in adult patients with severe asthma who require continuous treatment with ICS plus long-acting beta2-agonists (LABA), and chronic treatment with maintenance oral corticosteroid (OCS) therapy.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 2017. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. AstraZeneca's first Breakthrough Therapy Designation for a respiratory medicine. The trial showed annual asthma exacerbation rate reductions of 62%, 71% and 66% in the tezepelumab arms receiving either 70mg or 210mg every four weeks or 280mg every two weeks compared to placebo (p<0.001 for all comparisons), respectively. Tezepelumab is currently in development in the Phase III PATHFINDER clinical trial programme.Asthma affects 334 million people worldwide, and up to 10% of asthma patients have severe asthma, which may be uncontrolled despite high doses of standard-of-care asthma controller medicines and can require the use of chronic oral corticosteroids (OCS). 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 pressurised metered-dose inhalers and dry powder inhalers, as well as the Tezepelumab granted Breakthrough Therapy Designation by US FDAAstraZeneca's first Breakthrough Therapy Designation for a respiratory medicineDesignation based on Phase IIb PATHWAY data that demonstrated tezepelumab significantly reduced asthma exacerbations compared to placebo in severe asthmaAstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.A Breakthrough Therapy Designation is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically-significant endpoint over available medicines.The Breakthrough Therapy Designation is based on the tezepelumab Phase IIb PATHWAY data that showed a Currently-available biologic therapies only target T2-driven inflammation.
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