FDA approval of Tezspire for severe asthma

pharmafile | December 20, 2021 | News story | Sales and Marketing  

Tezpire (tezepelumab-ekko), manufactured by AstraZeneca and Amgen, has been approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 and older with severe asthma. This  is the only biologic for severe asthma approved with no phenotype or biomarker limitations.

Tezspire is a first-in-class biologic for severe asthma that acts at the top of the inflammatory cascade, targeting thymic stromal lymphopoietin (TSLP). It consistently and significantly reduced asthma exacerbations across Phase II and III clinical trials, including a broad population of severe asthma patients irrespective of key biomarkers, such as blood eosinophil counts, allergic status, and fractional exhaled nitric oxide (FeNO).

The treatment was approved following a Priority Review by the FDA, based on results from the PATHFINDER clinical trial programme. The application included results from the NAVIGATOR Phase III trial, in which Tezspire demonstrated efficacy across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy. Tezspire is the only biologic approved for severe asthma with no phenotype (such as eosinophilic or allergic), or biomarker limitation, within its approved label.

Professor Andrew Menzies-Gow, Director of the Lung Division, Royal Brompton Hospital, London, 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.”

Asthma is a disease with many root causes, affecting an estimated 339 million people globally. Approximately 10% of asthma patients have severe asthma. Due to the complexity of severe asthma, many patients have unclear or multiple drivers of inflammation and may not qualify for, or respond well to, a current biologic medicine. Severe, uncontrolled asthma is debilitating and patients experience frequent exacerbations, significant limitations on lung function, and a reduced quality of life.

Ana Ovey

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