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Sep 22, 2025 4:00 PM

European Advisory Panel Recommends Two AstraZeneca Drugs For Approval

AstraZeneca Plc (NASDAQ:AZN) and Amgen Inc.'s (NASDAQ:AMGN) Tezspire (tezepelumab) has been recommended for approval in the European Union (EU) for adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the WAYPOINT Phase 3 trial.

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In the WAYPOINT trial, Tezspire demonstrated a statistically significant and clinically meaningful reduction in nasal polyp severity, as measured by the co-primary endpoints: Nasal Polyp Score (NPS) by -2.08 and nasal congestion by -1.04 at week 52 compared to ...