AstraZeneca and Amgen’s asthma biologic approved in the US

By Rachel Arthur

- Last updated on GMT


Related tags Astrazeneca Amgen Asthma

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

The human monoclonal antibody acts at the top of the inflammatory cascade by targeting thymic stromal lymphopoietin (TSLP), an epithelial cytokine.

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. Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.

Priority review

Asthma affects around 339 million people worldwide; with around 10% of these affected by severe asthma (people with significant imitations on lung function, reduced quality of life, and an increased risk of mortality).

AstraZeneca and Amgen joined forces in 2012 to develop and commercialize five monoclonal antibodies from Amgen’s clinical inflammation portfolio, including Tezspire.

The treatment was approved following a priority review by the US Food and Drug Administration (FDA), based on results from Pathfinder and Navigator clinical trials.

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 of Allergy & Asthma Network, and President of the Global Allergy and Airways Patient Platform, said: “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.”

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

It is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous 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 updated the 2012 collaboration agreement for Tezspire: which sees both companies continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen.

AstraZeneca continues to lead development and Amgen continues to lead manufacturing. 

Amgen and AstraZeneca will jointly commercialize Tezspire in North America. Amgen will record product sales in the US, with AZ recording its share of US profits as Collaboration Revenue. Outside of the US, AstraZeneca will record product sales, with Amgen recording profit share as Other/Collaboration revenue.

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