EU Approves First Biologic for Severe Uncontrolled Asthma

Mark S. Lesney, PhD

September 26, 2022

The European Commission has approved tezepelumab (Tezspire, AstraZeneca) as an add-on maintenance treatment for patients 12 years and older who have severe asthma that is inadequately controlled with high-dose inhaled corticosteroids and another drug product.

"With the European approval of Tezspire, a first-in-class biologic acting at the top of the inflammation cascade, we have an opportunity to treat a broader population of patients with severe asthma, fulfilling a high unmet need in this disease," according to Guy Brusselle, MD, PhD, Department of Respiratory Medicine, Ghent University Hospital, Belgium, as quoted in the AstraZeneca press release.

Tezspire acts by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine, and is the first and only biologic approved in Europe for severe asthma for adults and adolescents with inadequately controlled severe asthma with no phenotype or biomarker limitations. In clinical trials, the most common adverse events in patients who received Tezspire were pharyngitis, rash, arthralgia, and injection site reactions, according to the company.

Tezspire has already been approved in the United States and other countries for the treatment of severe asthma.

The approval by the European Commission was based on results from the pivotal NAVIGATOR phase 3 trial, in which Tezspire demonstrated superiority in patients with severe asthma, compared with placebo, when added to standard therapy. The approval follows the recommendation by the Committee for Medicinal Products for Human Use of the European Medicines Agency in July 2022.

NAVIGATOR was funded by AstraZeneca and Amgen.

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