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(Alliance News) - AstraZeneca PLC on Wednesday its Tezpire severe asthma treatment has been approved in the EU by the European Commission.
The Cambridge-based pharmaceutical firm said Tezpire is an add-on maintenance treatment in patients aged 12 and older who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product.
The approval in the EU was based on results from the Pathfinder clinical trial programme, in which Tezpire showed superiority across "every primary and key secondary endpoint" in patients with severe asthma, compared to a placebo, when added to standard therapy.
AstraZeneca's Executive Vice President Mene Pangalos said: "Severe asthma continues to have a debilitating impact for people living with the disease, with many patients experiencing frequent exacerbations, an increased risk of hospitalisation and a significantly reduced quality of life. Tezspire is now the first and only biologic approved in Europe for patients with severe asthma with no phenotype or biomarker limitation and we look forward to bringing this important medicine to patients as quickly as possible."
A biologic is any pharmaceutical drug product that slows or stops damaging inflammation, which is manufactured in, extracted from, or semisynthesised from biological sources.
Tezspire has been approved in the US and other countries for the treatment of severe asthma.
Asthma is a heterogeneous disease affecting approximately 14 million people living with the disease in the European Union and an estimated 339 million people worldwide.
The approval came a day after AstraZeneca said its Evusheld treatment for Covid-19 had been approved for use in the EU, based on results from the Tackle Phase III Covid-19 treatment trial.
Shares were down 0.4% at 10,032.00 pence each on Wednesday morning in London.
By Xindi Wei; xindiwei@alliancenews.com
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