Tezspire approved for self-administration in the EU in a new pre-filled pen

AstraZeneca

13 January 2023 - New administration option for first and only severe asthma biologic approved in the EU with no phenotype or biomarker limitations.

AstraZeneca’s Tezspire (tezepelumab) has received a positive opinion from the EMA’s 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.

Read AstraZeneca press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , Europe