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AstraZeneca’s Tezspire recommended for approval in the EU by CHMP

The recommendation is for the treatment of severe asthma as an add-on therapy for patients 12 years and above


AstraZeneca (AZ) has received a recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the EU approval of Tezspire (tezepelumab) as an add-on therapy in patients 12 years and older with severe asthma.

The recommendation specifically outlines that patients eligible for the therapy diagnosed with severe asthma have been inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Tezspire is the first and only biologic recommended for EU approval in those with severe asthma with no phenotype or biomarker limitations.

The Committee based its positive opinion on data taken from the PATHFINDER clinical trial programme, while the marketing authorisation application featured results from the pivotal NAVIGATOR phase 3 trial, whereby Tezspire outperformed across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.

Tezspire was developed by AstraZeneca, in partnership with Amgen, as a first-in-class human monoclonal antibody It 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.

The treatment consistently and significantly reduced asthma exacerbations across the phase 2 and 3 clinical trials, involving a broad population of severe asthma patients, irrespective of key biomarkers.

Around 14 million people live with asthma in the EU and there are an estimated 339 million people worldwide, with up to 10% of asthma patients having severe asthma. Although the use of inhaled asthma controller medicine is recommended, currently available biologic treatments and oral corticosteroids (OCS), many severe asthma patients are still uncontrolled.

Due to the complexity of severe asthma, many patients display unclear or multiple drivers of inflammation and may be ineligible for or not respond well to a current biologic medicine.

Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ, said: “Despite recent advances in treatment, many asthma patients continue to experience debilitating symptoms, an increased risk of hospitalisation, and even death.

“[Tezspire is] the only biologic recommended for EU approval in severe asthma patients with no phenotype or biomarker limitation. [It] has consistently and significantly reduced exacerbations in clinical trials, and has the potential to transform care for a broad population of severe asthma patients.”

Article by
Fleur Jeffries

25th July 2022

From: Research, Regulatory



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