AstraZeneca: tezspire approved by EU
(CercleFinance.com) - AstraZeneca's Tezspire (tezepelumab) has been approved by the European Union (EU) as an add-on maintenance treatment for patients aged 12 years and older who suffer from severe asthma.
The European Commission approval was based on the results of the PATHFINDER clinical trial program, which included the pivotal phase III NAVIGATOR trial. Tezspire demonstrated superiority in all key primary and secondary endpoints in patients with severe asthma, compared to placebo, when added to standard therapy.
The approval follows the recommendation of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in July 2022.
Tezspire is the first and only biologic approved in Europe for severe asthma. It has consistently and significantly reduced asthma exacerbations throughout Phase II clinical trials.
Copyright (c) 2022 CercleFinance.com. All rights reserved.
The European Commission approval was based on the results of the PATHFINDER clinical trial program, which included the pivotal phase III NAVIGATOR trial. Tezspire demonstrated superiority in all key primary and secondary endpoints in patients with severe asthma, compared to placebo, when added to standard therapy.
The approval follows the recommendation of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in July 2022.
Tezspire is the first and only biologic approved in Europe for severe asthma. It has consistently and significantly reduced asthma exacerbations throughout Phase II clinical trials.
Copyright (c) 2022 CercleFinance.com. All rights reserved.