17th Oct 2025 21:44
(Alliance News) - Amgen Inc and AstraZeneca on Friday said the US Food & Drug Administration had broadened the indication for Tezspire to a second disease.
In a statement, Thousand Oaks, California-based Amgen and Cambridge, England-based AstraZeneca said Tezspire has been approved for the add-on maintenance treatment of inadequately controlled chronic rhinosinusitis with nasal polyps in adult and pediatric patients aged 12 years and older.
Tezspire is the first and only biologic approved for CRSwNP that targets thymic stromal lymphopoietin.
The approval was based on efficacy and safety data from the Waypoint phase III trial, which were presented at the 2025 American Academy of Allergy Asthma & Immunology/World Allergy Organization Joint Congress.
In the trial, Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity and showed near-elimination of the need for surgery and significant reduction in systemic corticosteroid use versus placebo.
The safety and tolerability profile of Tezspire in the trial was generally consistent with its established profile in severe asthma.
Regulatory applications are currently under review in Europe, China, Japan and several other countries based on the trial.
Tezspire is also indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.
In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for Tezspire. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen.
Amgen closed up 0.4% at USD297.86 in New York on Friday. AstraZeneca closed little changed at 12,558.00 pence each in London.
By Jeremy Cutler, Alliance News reporter
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