The US Food and Drug Administration (FDA) has granted approval to AstraZeneca and Amgen’s Tezspire (tezepelumab-ekko) as an add-on maintenance therapy for severe asthma in adults and paediatric individuals of the age 12 years and above.
Tezspire is a human monoclonal antibody that potentially hinders the activity of thymic stromal lymphopoietin (TSLP), an epithelial cytokine.
Under a partnership agreement signed in 2012 and updated last year, the companies are jointly developing Tezspire.
The approval comes after the FDA granted priority review for application seeking approval for Tezspire and is based on data from the PATHFINDER trial programme.
The filing also comprised data from the Phase III NAVIGATOR trial where the Tezspire plus standard treatment showed superiority across all primary as well as key secondary goals in severe asthma patients versus placebo.
In addition, no clinically significant variations in safety data between the Tezspire and placebo arms were reported in this trial.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Today’s positive decision marks the first time the FDA has approved a biologic for asthma without phenotypic limitation and irrespective of biomarker levels.
“With the approval of Tezspire, physicians will now be able to offer an important new treatment that has the potential to transform care for a broad population of severe asthma patients.”
Pharyngitis, back pain and arthralgia were reported to be the most common side effects associated with Tezspire in clinical trials.
Currently, the antibody is being reviewed in the European Union, Japan as well as various other regulatory agencies across the globe.
It is claimed to be the first-ever biologic to steadily and substantially lower asthma exacerbations across Phase II and III trials.
These trials enrolled a wider set of severe asthma patients regardless of crucial biomarkers, including allergic status, blood eosinophil counts and fractional exhaled nitric oxide (FeNO).
Furthermore, Tezspire is the only biologic that has received approval to treat severe asthma without phenotype or biomarker limitations.