Benzinga | Dec 20, 2021 04:44AM EST

AstraZeneca Announced Tezspire Approved in the US for Severe Asthma

AstraZeneca and Amgen's Tezspire (tezepelumab-ekko) has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma.1

Tezspire was approved following a Priority Review by the US Food and Drug Administration (FDA) and based on results from the PATHFINDER clinical trial programme. The application included results from the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.2

Tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.2-5 It is the first and only biologic to consistently and significantly reduce asthma exacerbations across Phase II and III clinical trials which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).2,3,6-13 Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.1

Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, UK, and principal investigator of the NAVIGATOR trial, said: "Due to the complex and heterogeneous nature of severe asthma and despite recent advances, many patients continue to experience frequent exacerbations, an increased risk of hospitalisation and a significantly reduced quality of life. Tezspire represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma."

Tonya Winders, President and CEO ofAllergy & Asthma Network, and President of the Global Allergy and Airways Patient Platform, said: "Severe asthma continues to have a debilitating impact on many of the 34 million people living with the disease worldwide, affecting their breathing and limiting aspects of day-to-day life. The approval of Tezspire is long-awaited positive news for the asthma community. For the first time, many people living with severe asthma have the opportunity to receive treatment regardless of the cause of their inflammation."

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: "Today's positive decision marks the first time the FDA has approved a biologic for asthma without phenotypic limitation and irrespective of biomarker levels. With the approval of Tezspire, physicians will now be able to offer an important new treatment that has the potential to transform care for a broad population of severe asthma patients."

In clinical studies, the most common adverse reactions in patients who received Tezspire were pharyngitis, arthralgia and back pain.1

Results from the NAVIGATOR Phase III trial were published inThe New England Journal of Medicine in May 2021. There were no clinically meaningful differences in safety results between the Tezspire and placebo groups in the NAVIGATOR trial.2

The application for Tezspire was granted Priority Review, a designation given to applications for medicines that offer significant advantages over available options by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.14

Tezspire is under regulatory review in the EU, Japan and several other countries around the world.