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AstraZeneca’s severe asthma treatment approved in EU for self-administration

Most healthcare providers, patients and caregivers are able to successfully use the pre-filled pen


AstraZeneca’s Tezspire (tezepelumab) has been approved for self-administration in patients with severe asthma aged 12 years and older after it received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP).

The CHMP’s opinion, which can be implemented without the need for a European Commission decision due to the nature of the type-2 label variation, makes AZ’s pre-filled pen the first and only severe asthma biologic approved in the EU with no phenotype of biomarker limitations.

The approval for self-administration was based on results from the PATHFINDER clinical trial programme, which included results from the PATH-BRIDGE phase 1 trial and the PATH-HOME phase 3 trial.

Throughout the PATH-HOME trial, 92% of healthcare providers, patients and caregivers were able to successfully administer Tezspire both in the clinic and at home. The trial also demonstrated for the first time that adolescents could successfully self-administer Tezspire.

Also included in the PATHFINDER clinical trial programme was the pivotal NAVIGATOR phase 3 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.

“Severe asthma continues to have a debilitating impact for people living with the disease,” said Professor Ian Pavord, professor of respiratory medicine at the University of Oxford and honorary consultant physician at the Oxford University Hospitals.

He continued: “I believe the approval of the Tezspire pre-filled pen will be welcome news for physicians and patients in Europe as it offers increased choice and greater flexibility when administering this important medicine.”

Asthma affects approximately 14 million people in the EU and an estimated 339 million people worldwide, with up to 10% of asthma patients living with severe asthma. Despite the use of inhaled asthma controller medicine, currently available biologic therapies and oral corticosteroids, many severe asthma patients remain uncontrolled.

Severe, uncontrolled asthma is debilitating, with patients experiencing frequent exacerbations, significant limitations on lung function and a reduced quality of life. Patients with severe asthma are at an increased risk of mortality and compared to patients with persistent asthma have twice the risk of asthma-related hospitalisations.

Tezspire is being developed by AZ in collaboration with Amgen as a first-in-class human monoclonal antibody and has been approved in the EU, US and other countries for the treatment of severe asthma.

Article by
Emily Kimber

13th January 2023

From: Regulatory



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