AstraZeneca’s Tezspire (tezepelumab) has been recommended for marketing authorisation by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency as an add-on therapy in patients aged 12 years and above suffering with severe asthma.
Tezspire has been recommended as an add-on therapy for these patients whose condition is not sufficiently controlled with high dose inhaled corticosteroids besides another medicinal product for maintenance treatment.
The CHMP has given its positive opinion based on results from the PATHFINDER clinical trial programme.
The application for marketing authorisation featured results from the pivotal NAVIGATOR Phase III trial in which Tezspire showed superiority across every primary and key secondary endpoint in patients suffering with severe asthma, as against placebo, when added to standard therapy.
Claimed to be the first and only biologic for severe asthma, Tezspire acts at the top of the inflammatory cascade by hindering thymic stromal lymphopoietin (TSLP), an epithelial cytokine.
It has significantly as well as consistently cut down asthma exacerbations across Phase II and III clinical trials, which included a wide population of severe asthma patients irrespective of important biomarkers.
These biomarketrs included blood eosinophil counts, allergic status and fractional exhaled nitric oxide (FeNO).
AstraZeneca executive vice president for BioPharmaceuticals research and development Mene Pangalos 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.”
In December 2021, Tezspire was given approval in the US as an add-on maintenance treatment for adult and paediatric patients aged 12 years and older with severe asthma.
This drug is currently under regulatory review in Japan and several other countries.