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.

On Thursday, the Institute for Clinical and Economic Review (ICER) released its final report assessing the comparative clinical effectiveness and value of tezepelumab. ICER said its health-benefit price benchmark range for the drug is between $9,000-$12,100 per year.

Tezepelumab was approved following a Priority Review by the FDA and based on results from the PATHFINDER clinical trial program. The application included results from the pivotal NAVIGATOR phase 3 trial in which the drug demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared with placebo, when added to standard therapy.

“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 a statement.

The company said it is “the first and only biologic to consistently and significantly reduce asthma exacerbations across phase 2 and 3 clinical trials, which included a broad population of severe asthma patients irrespective of key biomarkers, including blood eosinophil counts, allergic status and fractional exhaled nitric oxide.”

The most common adverse reactions were nasopharyngitis, upper respiratory tract infection and headache.

The biologic is under regulatory review in the European Union, Japan, and several other countries around the world.