AZN Gets CHMP Nod for Label Expansion of Koselugo & Tezspire

Core Insights - AstraZeneca's Koselugo has received a positive recommendation from the CHMP for expanded use in treating symptomatic, inoperable plexiform neurofibromas in adult patients with neurofibromatosis type 1 in the EU [1][6] - The recommendation is supported by data from the phase III KOMET study, which showed a significant objective response rate of 20% for Koselugo compared to 5% for placebo [2][6] - AstraZeneca's Tezspire has also been recommended for the treatment of adult patients with chronic rhinosinusitis with nasal polyps in the EU, based on the phase III WAYPOINT study [7][8] AstraZeneca's Product Approvals - Koselugo is already approved for certain pediatric patients with NF1 in multiple countries, including the US, EU, Japan, and China, and has recently gained approval for adult patients in Japan [3] - Tezspire is currently approved for severe asthma in various regions and is under review for treating chronic rhinosinusitis with nasal polyps in the US, with a decision expected on October 19, 2025 [9] Financial Performance - Year-to-date, AstraZeneca's shares have increased by 18.2%, outperforming the industry average rise of 3.5% [4]