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AstraZeneca and Amgen Report the CHMP’s Positive Opinion of Tezspire (Tezepelumab) for CRSwNP

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  • The CHMP has recommended Tezspire for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP); regulatory review is ongoing in the US, China, Japan & other countries
  • Opinion was based on the P-III (WAYPOINT) study assessing Tezspire (SC) vs PBO to treat adults with severe CRSwNP for 52wks., followed by a post-treatment follow-up duration of 12-24wks.
  • Study met its co-1EPs, with a reduction in nasal polyp severity (per NPS) by -2.08 & a decrease in nasal congestion (per NCS) by -1.04 at 52wks., plus Tezspire reduced surgery needs by 98% & systemic corticosteroid use by 89%; results were presented at AAAAI/WAO’25 & published in The NEJM

Ref: AstraZeneca | Image: AstraZeneca and Amgen | Press Release

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