Tezepelumab Granted Breakthrough Therapy Designation by FDA for Severe Asthma

Officials with the FDA recently granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma without an eosinophilic phenotype, Amgen and AstraZeneca announced in a press release.

Tezepelumab is a potential first-in-class drug that blocks thymic stromal lymphopoietin (TSLP), an upstream modulator of multiple inflammatory pathways, according to Amgen. Blocking TSLP may prevent the release of pro-inflammatory cytokines by immune cells, resulting in the prevention of asthma exacerbations and improved asthma control, according to the press release.

The designation is based on data from the phase 2b PATHWAY trial, which showed a significant reduction in the annual asthma exacerbation rate compared with a placebo over a 52-week treatment period.

The trial evaluated the efficacy and safety of 3-dose regimens of tezepelumab as an add-on therapy in patients with a history of asthma exacerbations and uncontrolled asthma receiving inhaled corticosteroids/long-acting beta-agonist with or without oral corticosteroids and additional asthma controllers compared with a placebo. Participants included patients with severe asthma independent of baseline blood eosinophil count or other type 2 inflammatory biomarkers.

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