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AstraZeneca: CHMP Recommends Tezspire For Severe Asthma In EU

British drug major AstraZeneca Plc. (AZN.L,AZN) Monday said that Tezspire (tezepelumab) has been recommended for marketing authorisation in the European Union for the treatment of severe asthma.

The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has recommended the drug as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

AstraZeneca said it is the first and only biologic recommended for EU approval in patients with severe asthma with no phenotype or biomarker limitations.

The CHMP recommendation is based on positive opinion on results from the PATHFINDER clinical trial programme.

The marketing authorisation application included results from the pivotal NAVIGATOR Phase III trial in which Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma, compared to placebo, when added to standard therapy.

Tezspire is the first and only biologic for severe asthma that acts at the top of the inflammatory cascade by blocking thymic stromal lymphopoietin or TSLP, an epithelial cytokine.

Tezspire is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody that inhibits the action of TSLP.

Results from the NAVIGATOR Phase III trial were published in The New England Journal of Medicine in May 2021.

In clinical trials, the most common adverse events in patients who received Tezspire were pharyngitis, rash, arthralgia and injection site reactions.

Tezspire is approved in the US for the add-on maintenance treatment of adult and paediatric patients aged 12 years and older with severe asthma. It is under regulatory review in Japan and many other countries around the world. The drug is also in development for other potential indications.

In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE.

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