UK-based pharmaceutical company AstraZeneca announced on Friday that its Tezspire (tezepelumab) has received a positive opinion from the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma.

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. Tezspire is the only biologic approved for severe asthma with no phenotype (e.g. eosinophilic or allergic) or biomarker limitation within its approved label.

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.'

AstraZeneca anticipates a regulatory decision by the US Food and Drug Administration (FDA) 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.