British drug major AstraZeneca Plc (AZN.L,AZN) Wednesday said its Tezspire (tezepelumab) has been approved in the European Union for the treatment of severe asthma.
Tezspire is approved 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.
It is the first and only biologic approved by the European Commission in patients with severe asthma with no phenotype or biomarker limitations.
The approval follows the recommendation by The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency in July 2022.
The approval was based on results from the PATHFINDER clinical trial programme, which included the pivotal NAVIGATOR Phase III trial. Tezspire demonstrated superiority across every primary and key secondary endpoint in patients with severe asthma in the trial, compared to placebo, when added to standard therapy.
In clinical trials, the most common adverse events in patients who received Tezspire were pharyngitis, rash, arthralgia and injection site reactions.
The NAVIGATOR Phase III trial’s results were published in The New England Journal of Medicine in May 2021.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, AstraZeneca, 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…”
Tezspire is being developed by AstraZeneca in collaboration with Amgen as a first-in-class human monoclonal antibody.
Tezspire has been approved in the US and other countries for the treatment of severe asthma, and regulatory reviews are ongoing in additional countries.
It is also in development for other potential indications including chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria and eosinophilic esophagitis or EoE. In October 2021, tezepelumab was granted Orphan Drug Designation by the FDA for the treatment of EoE.
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