FDA to Review BLA for Tezepelumab for Severe Asthma Treatment

By Adam Hochron
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The manufacturer of tezepelumab, an investigational treatment for severe asthma, has submitted a Biologics License Application to the FDA following a phase 3 trial that showed superiority in several areas compared to placebo. 

According to a release from the manufacturer, the NAVIGATOR trial showed tezepelumab demonstrated a significant improvement in the annualized asthma exacerbation rate in patients with severe, uncontrolled asthma compared to placebo. The release noted that the treatment targets and blocks thymic stromal lymphopoietin, which has been shown to play a role in asthma inflammation. 

During the trial, the treatment showed benefits in reducing the exacerbation rate regardless of baseline eosinophil count while improving factors like lung function measurement, asthma control, and health-related quality of life compared to placebo. The most frequently reported adverse events during the NAVIGATOR trial were nasopharyngitis, upper respiratory tract infection, and headache. 

“Severe asthma remains uncontrolled for many patients despite current therapies for this complex and often debilitating condition,” said David M. Reese, MD, executive vice president of Research and Development at Amgen, in the release. “This submission brings us one step closer to providing this potentially transformative treatment option to a broad population of severe asthma patients, across phenotypes and irrespective of biomarkers.” 

The FDA had previously granted tezepelumab Breakthrough Therapy Designation for patients with severe asthma, without an eosinophilic phenotype. 

Full results from the PATHFINDER clinical program and NAVIGATOR trial will be presented at the American Thoracic Society 2021 International Conference.



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