In pursuit of a blockbuster, Amgen and AstraZeneca score priority review for asthma drug tezepelumab
Amgen and AstraZeneca are one big step closer to realizing their blockbuster dreams for tezepelumab after the FDA granted a priority review for the asthma drug.
Despite the challenge of battling Regeneron and Sanofi’s Dupixent, tezepelumab has been pegged for peak sales of $2.5 billion. With AstraZeneca leading development, Amgen spearheading manufacturing and both sharing commercialization responsibilities, the two pharma giants have been vocal about their optimism.
In particular, as AstraZeneca’s head of biopharmaceuticals R&D Mene Pangalos noted they believe the drug would deliver a much-needed alternative to severe asthma patients who “remain uncontrolled and at risk of asthma attacks despite the availability of inhaled and biologic medicines.”
By blocking an epithelial cytokine called thymic stromal lymphopoietin, tezepelumab is designed to target the top of the inflammatory cascade.
Added to standard of care, the once-monthly antibody injections cut the rate of severe asthma attacks by more than half in a Phase III study, with consistent results regardless of patients’ baseline eosinophil counts and allergy status.
It had not been all rosy, though, as concerns arose about a failure to cut down on the number of oral corticosteroids patients took — a metric Dupixent was able to get down. But Amgen and AstraZeneca attributed that to trial design and argued the priority for clinicians is to get the severe asthma patients who are ineligible for existing biologics onto therapy, giving them an opportunity to carve out market share.
The FDA is now set to make a decision during the first quarter of 2022.