Key Takeaways AstraZeneca gained FDA approval to extend Koselugo use to adult NF1 patients with symptomatic, inoperable PN.Koselugo's label was also recently expanded in the EU, Japan and other countries, with more reviews ongoing.AZN's KOMET study showed a 20% overall response rate for Koselugo versus 5% with placebo by cycle 16.AstraZeneca (AZN) announced that the FDA has approved its oral, selective MEK inhibitor, Koselugo (selumetinib), for expanded use. The drug is now indicated to treat symptomatic, i ...

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]