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Tezspire approved in US for severe asthma

AstraZeneca and Amgen’s monoclonal antibody Tezspire is now available to control dangerous exacerbations in all adults and children aged 12 years and above with severe asthma

AstraZeneca

After being granted a Priority Review in July 2021, AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) has been approved by the US Food and Drug Administration (FDA)  as an add-on maintenance treatment for adults and children aged 12 years and  with severe asthma.

The approval is supported by data from the PATHFINDER clinical programme involving the phase 2b PATHWAY trial and two phase 3 trials, NAVIGATOR and SOURCE. Results from the pivotal NAVIGATOR trial saw Tezspire demonstrate superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.

“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,” said Professor Andrew Menzies-Gow, director of the lung division, Royal Brompton Hospital, London and principal investigator of the NAVIGATOR trial.

The decision by the FDA was welcomed by Tonya Winders from the Allergy & Asthma Network and Global Allergy and Airways Patient Platform. “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.”

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. It is the first and only biologic to consistently and significantly reduce asthma exacerbations across a broad population of severe asthma patients, said the companies.

Around 10% of people living with the condition are considered to have severe asthma, a complex and often uncontrolled form. Severe asthma is debilitating, with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life, as well as an increased risk of mortality.

In 2020, Amgen and AstraZeneca updated a 2012 collaboration agreement for Tezspire to continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit inventor royalty to Amgen.

Tezspire is also in development for several other indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis, for which it was granted orphan drug designation by the FDA in October this year.

Article by
Hugh Gosling

20th December 2021

From: Research

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