CHMP issues positive recommendation to first and only biologic for asthma patients

pharmafile | July 26, 2022 | News story | Manufacturing and Production  

AstraZeneca’s Tezspire (tezepelumab) has been recommended for marketing authorisation in the 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 CHMP has based its positive opinion on results from the PATHFINDER clinical trial programme. The marketing authorisation application included results from the NAVIGATOR Phase III trial, in which Tezspire showed superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when combined with standard therapy.

Tezspire is the first and only biologic for severe asthma that blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine. It dramatically reduced asthma exacerbations across Phase II and III clinical trials.

Dr Stephanie Korn, investigator for the NAVIGATOR trial, commented: “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, added: “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.”

Tezspire was approved as an add-on maintenance treatment for severe asthma in the US in December 2021, and is currently under regulatory review in Japan and numerous other countries.

Lina Adams

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