FDAnews
www.fdanews.com/articles/209504-ec-approves-astrazenecas-tezspire-for-severe-asthma

EC Approves AstraZeneca’s Tezspire for Severe Asthma

September 22, 2022

The European Commission (EC) has approved AstraZeneca’s Tezspire (tezepelumab) as an add-on maintenance treatment in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product.

Tezspire is the first biologic approved in Europe for severe asthma. It acts by blocking a cytokine that is key in the initiation and persistence of allergic, eosinophilic and other types of airway inflammation associated with severe asthma, including airway hyperresponsiveness.

The approval followed a recommendation by the European Medicines Agency’s Committee for Medicinal Products for Human Use in July.

The drug was developed in a collaboration with AstraZeneca and Amgen that dates back to 2012.

View today's stories