FDA Approves Tezepelumab for Severe Asthma

The FDA Friday approved tezepelumab, the first biologic that targets thymic stromal lymphopoietin (TSLP), for severe asthma.

Levels of TSLP, an epithelial cytokine, are linked with disease severity, airway obstruction, and resistance to glucocorticoids. The biologic, to be sold as Tezspire by Amgen and AstraZeneca, was approved as an add-on maintenance treatment of adult and pediatric patients aged 12 years and older.

Results of the drug, published last spring, showed that it cut exacerbations by 56%. It will become the first and only biologic for severe asthma that is not labeled for a specific phenotype—eosinophilic or allergic—or biomarker.

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