New administration option for Tezspire, first and only severe asthma biologic approved in the EU with no phenotype or biomarker limitations.- AstraZeneca

The CHMP opinion can be implemented without the need for a European Commission decision due to the nature of the Type-II label variation. 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 is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.

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".

Tezspire pre-filled pen; 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). Both are administered every four weeks. The Tezspire pre-filled pen enables patients and caregivers to self-administer the medicine at home or in clinic via a simple process. The device is fitted with a safety guard and viewing window and has audible clicks at the start and end of the injection to guide patients.