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news.The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) and granted priority review for tezepelumab, which is being developed by AstraZeneca and Amgen, to treat patients with asthma.
Tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations. Credit: AstraZeneca.
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The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) and granted priority review for tezepelumab, which is being developed by AstraZeneca and Amgen, to treat patients with asthma.
Tezepelumab is a potential human monoclonal antibody and is also claimed to be the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population across Phase II and III clinical trials.
AstraZeneca stated that the acceptance of BLA was based on PATHFINDER clinical trials programme results and the pivotal NAVIGATOR Phase III trial results.
Tezepelumab showed superiority across every primary and key secondary endpoint compared to placebo in the NAVIGATOR trial.
This trail was conducted on patients suffering with uncontrolled asthma, who are currently taking medium- or high-dose inhaled corticosteroids (ICS) and at least one additional controller medicine with or without oral corticosteroids (OCS).
No clinically meaningful differences in safety results were reported between the tezepelumab and placebo groups during the NAVIGATOR trial.
However, the most frequently reported adverse events with tezepelumab included upper respiratory tract infection, headache and nasopharyngitis.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “This decision brings us a step closer to delivering a much-needed, first-in-class medicine for asthma patients, many of whom remain uncontrolled and at risk of asthma attacks despite the availability of inhaled and biologic medicines.
“Tezepelumab has demonstrated reductions in exacerbations irrespective of blood eosinophil counts, allergy status and fractional exhaled nitric oxide, and has the potential to transform treatment for a broad population of severe asthma patients.”
In September 2018, tezepelumab obtained FDA breakthrough therapy designation for patients with severe asthma without an eosinophilic phenotype.
