The decision comes after the FDA granted the drug, Tezspire (tezepelumab), Priority Review status on positive results from the PATHFINDER clinical trial program.
The U.S. Food and Drug Administration (FDA) has approved AstraZeneca and Amgen‘s candidate drug for severe asthma in adults and children ages 12 years and older.
The decision comes after the FDA granted the drug, Tezspire (tezepelumab), Priority Review status on positive results from the PATHFINDER clinical trial program. The approval was also contingent on findings from the NAVIGATOR Phase III study, where Tezspire successfully met all primary and secondary endpoints when it was added to standard therapy, compared to a placebo. Details of the NAVIGATOR trial were published in May this year in The New England Journal of Medicine.
Tezspire is a first-in-class biologic that targets thymic stromal lymphopoietin (TSLP), a type of epithelial cytokine that initiates an overreactive immune response to many kinds of airway inflammations. Blocking TSLP can prevent the release of pro-inflammatory cytokines by immune cells, which results in the improvement of asthma control and prevention of exacerbations.
The drug is the only biologic that delivered significant and consistent reductions in severe asthma cases in Phase II and Phase III studies. It is also the only severe asthma therapy with no allergic or eosinophilic phenotype or a biomarker limitation. It is meant as an add-on maintenance treatment for severe asthma but not indicated for status asthmaticus, acute exacerbations, or acute bronchospasm.
“Asthma is a complex and chronic inflammatory disease that affects everyone differently. By working at the top of the inflammation cascade, Tezspire helps stop the inflammation that causes asthma attacks at the source and has the potential to treat a broad population of people with severe asthma, including those who have historically lacked effective treatment options,” commented Dr. David M. Reese, the executive vice president of R&D at Amgen, in a statement.
There are around 2.5 million patients diagnosed with severe asthma worldwide, and approximately one million are in the U.S. Hence, the approval of Tezspire offers a ray of hope for sufferers everywhere, regardless of what caused their inflammation. Many patients do not fully respond to currently available biologics and oral corticosteroids and, thus, fail to receive proper treatment. In addition, severe asthma comes with a huge socio-economic burden as these uncontrolled cases account for 50% of asthma-related costs.
Aside from the FDA’s approval, Tezspire is currently under review in Japan, the European Union, and other countries for the same indication.
The drug is also being developed for other potential indications, including chronic rhinosinusitis with nasal polyps, chronic obstructive pulmonary disease, eosinophilic esophagitis, and chronic spontaneous urticaria.
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