Asthma treatment: AstraZeneca Tezspire approved for self-administration in EU in new pre-filled pen

The approval for self-administration was based on results from the PATHFINDER clinical trial programme, which included results from the PATH-BRIDGE Phase I trial and the PATH-HOME Phase III trial. The majority (92%) of healthcare providers, patients and caregivers were able to successfully administer Tezspire both in the clinic and at home throughout the PATH-HOME trial. The improvements in asthma control and the safety profile of Tezspire observed in the PATH-HOME trial were consistent with previous clinical trials.

Tezspire will be available as a fixed-dose 210mg subcutaneous injection via a pre-filled, single-use auto-injector (the Tezspire pre-filled pen), in addition to the pre-filled, single-use syringe (Tezspire pre-filled syringe).

Professor Ian Pavord, Professor of Respiratory Medicine at the University of Oxford and Honorary Consultant Physician at the Oxford University Hospitals, said: “Severe asthma continues to have a debilitating impact for people living with the disease. 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.”

Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, said: “Tezspire is the first and only biologic approved in Europe for patients with severe asthma with no phenotype or biomarker limitation. With the approval of the Tezspire pre-filled pen, we can give patients in Europe greater flexibility and support physicians in treating a broad population of severe asthma patients.”

AstraZeneca anticipates a regulatory decision by the US Food and Drug Administration (USFDA) on self-administration and the new pre-filled pen in the first half of 2023. Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan and other countries.