The European Commission has recommended authorizing the marketing of zepelumab (tezspire) of Astra Zeneca as additional maintenance therapy in patients 12 years of age or older asthma grave insufficiently controlled by the administration of high doses of inhaled corticosteroids at the same time as another drug. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has based its positive opinion on the results of the clinical trial program Scout. The application for authorization included the results of the pivotal phase III trial Navigator. Thus, the drug demonstrated superiority on all primary and secondary endpoints in patients with severe asthma, compared to the use of placebo, when incorporated into standard treatment.
5% of the adult population suffers from asthma in Spain and 3.9% from severe uncontrolled asthma
In Spain, 5% of the adult population suffers from asthma. Among them, 3.9% suffer from severe uncontrolled asthma. That is, a debilitating type of asthma where patients may experience frequent asthma attacks and significant limitations in lung function and quality of life.
“This positive review is very encouraging news for patients with severe asthma in Europe. Our goal is to help prevent exacerbations, which significantly affect the quality of life of those who suffer from this chronic condition.” pointed out Ana PerezDirector of Medical and Regulatory Affairs of AstraZeneca.
Tezepelumab is the first biologic treatment for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin, an epithelial cytokine. Administration of this drug significantly reduced asthma exacerbations in phase II and III clinical trials. Both of these trials included a large sample of patients with severe asthma across key biomarkers, including blood eosinophil count, allergic status and fraction of expired nitric oxide. In addition, the most frequently observed adverse effects were pharyngitis, arthralgia and back pain.
The most frequently observed adverse effects were pharyngitis, arthralgia and back pain.
Finally, there were no clinically meaningful differences in safety outcomes between the placebo and drug groups. The results of the phase III Navigator trial have been published in The New England Journal of Medicine.