European Advisory Panel Recommends Two AstraZeneca Drugs For Approval

Group 1: Tezspire Approval and Clinical Results - AstraZeneca and Amgen's Tezspire has been recommended for approval in the EU for adult patients with chronic rhinosinusitis with nasal polyps based on the WAYPOINT Phase 3 trial results [1][3] - In the WAYPOINT trial, Tezspire showed a statistically significant reduction in nasal polyp severity, with a Nasal Polyp Score reduction of -2.08 and nasal congestion reduction of -1.04 at week 52 compared to placebo [2] - Tezspire also demonstrated a near-complete elimination of the need for surgery (98%) and a significant reduction in the need for systemic corticosteroid treatment (89%) compared to placebo [2] Group 2: Koselugo Approval and Clinical Results - The CHMP recommended approving Koselugo for symptomatic, inoperable plexiform neurofibromas in adult patients with neurofibromatosis type 1 based on the KOMET Phase 3 trial results [4] - Koselugo showed a statistically significant objective response rate of 20% compared to 5% with placebo by cycle 16 in the primary analysis of the trial [4] - The safety profile of Koselugo in the KOMET trial was consistent with its known profile and established use in pediatric patients [5] Group 3: Market Reaction - AstraZeneca's stock increased by 1.78% to $77.64, while Amgen's stock decreased slightly to $295.28 at the time of publication [5]