July 25, 2022: “AstraZeneca’s Tezspire (tezepelumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on results from the PATHFINDER clinical trial programme.
The marketing authorisation application included results from the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.
Tezspire is the first and only biologic for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin (TSLP), an epithelial cytokine.
Tezspire consistently and significantly reduced asthma exacerbations across Phase II and III 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 (FeNO).
Dr. Stephanie Korn, Senior Physician in Pneumology and Respiratory Medicine at IKF Pneumologie Mainz and Thoraxklinik Heidelberg, Germany, and investigator for the NAVIGATOR trial said: “Due to the complexity of severe asthma, about 60% of patients have multiple drivers of inflammation.
Tezspire is a first-in-class biologic acting at the top of the inflammation cascade and a much-needed potential treatment for patients who continue to struggle with severe, uncontrolled asthma.”
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Despite recent advances in treatment, many asthma patients continue to experience debilitating symptoms, an increased risk of hospitalisation, and even death.
The only biologic recommended for EU approval in severe asthma patients with no phenotype or biomarker limitation, Tezspire has consistently and significantly reduced exacerbations in clinical trials, and has the potential to transform care for a broad population of severe asthma patients.”
Results from the NAVIGATOR Phase III trial were published in The New England Journal of Medicine in May 2021. There were no clinically meaningful differences in safety results between the Tezspire and placebo groups in the NAVIGATOR trial.
In clinical trials, the most common adverse events in patients who received Tezspire were pharyngitis, rash, arthralgia and injection site reactions.
Tezspire was approved as an add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma in the US in December 2021 and is under regulatory review in Japan and many other countries around the world.”