Tezepelumab-ekko (Tezspire) has been approved by the Food and Drug Administration (FDA) as an add-on maintenance therapy for people ages 12 years and older with severe asthma symptoms not controlled by current medication. The drug was initially granted breakthrough therapy status by the FDA because preliminary clinical evidence demonstrated that it might provide substantial improvement over other available therapy on at least one clinically significant end point. Tezepelumab-ekko is administered subcutaneously once every four weeks by a health care provider. It should not be used to treat acute asthma symptoms or acute exacerbations, acute bronchospasm, or status asthmaticus.

Tezepelumab-ekko is a monoclonal antibody and a thymic stromal lymphopoietin blocker. Thymic stromal lymphopoietin is a cytokine that plays a role in the regulation of the immune response in asthma and in the differentiation of hematopoietic cells (blood cells).

The safety and effectiveness of tezepelumab-ekko were demonstrated in two randomized, double-blind, parallel-group, placebo-controlled clinical trials in which the drug or a placebo was administered every four weeks for a year. The two trials had a combination of 1,609 patients ages 12 years and older with severe asthma. Those who received tezepelumab-ekko had a significant reduction in the annualized rate of asthma attacks and fewer asthma attacks requiring ED visits or hospitalizations compared with those receiving placebo.

The most common adverse effects of tezepelumab-ekko are pharyngitis, arthralgia, and back pain. Hypersensitivity reactions such as rash or allergic conjunctivitis are possible. Because of tezepelumab-ekko's effect on the immune system, live attenuated vaccines should not be given during treatment and helminth infections should be treated prior to starting treatment.

For complete prescribing info for tezepelumab-ekko, go to http://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761224s000lbl.pdf.