FDA approves tezepelumab for severe asthma
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The FDA has approved tezepelumab for add-on maintenance treatment of adults and children aged 12 years and older with severe asthma.
Tezepelumab (Tezspire, Amgen/AstraZeneca) is a first-in-class biologic for severe asthma that aids in stopping inflammation that causes asthma exacerbations by targeting thymic stromal lymphopoietin, according to a company press release.
Tezepelumab does not have a phenotype (eosinophilic or allergic) or biomarker limitation within its approved label, according to the release.
“Today’s approval by the FDA marks the first time patients and their physicians will have a biologic option for severe asthma without phenotypic limitations and irrespective of biomarker levels,” David M. Reese, MD, executive vice president of Research and Development at Amgen, said in the release. “Asthma is a complex and chronic inflammatory disease that affects everyone differently. By working at the top of the inflammation cascade, Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options.”
Tezepelumab was approved following an FDA priority review and approval was based on results of the PATHFINDER clinical trial program, according to the release.
Results of the NAVIGATOR phase 3 trial, which demonstrated a significant and clinically meaningful reduction in exacerbations in patients with severe, uncontrolled asthma, were published in The New England Journal of Medicine in May.
“Due to the complex and heterogeneous nature of severe asthma and despite recent advances, many patients continue to hospitalization and a significantly reduced quality of life,” Andrew Menzies-Gow, BSc, MBBS, PhD, FRCP, director of the lung division at Royal Brompton Hospital in London and principal investigator of the NAVIGATOR trial, said in the release. “Tezspire represents a much-needed new treatment for the many patients who remain underserved and continue to struggle with severe, uncontrolled asthma.”
Tezepelumab is under regulatory review in the European Union, Japan and several other countries, according to the release.