AstraZeneca’s Tezspire approved in E.U. in for severe asthma

The company states: "AstraZeneca’s Tezspire, or tezepelumab, has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use 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.The majority of healthcare providers, patients and caregivers were able to successfully administer Tezspire both in the clinic and at home throughout the PATH-HOME trial.2 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 or biomarker limitation within its approved label."