AstraZeneca’s Koselugo approved in EU for plexiform neurofibromas

Alexion, AstraZeneca (AZN) Rare Disease’s Koselugo, an oral, selective MEK inhibitor, has been approved in the European Union, EU, for the treatment of symptomatic, inoperable plexiform neurofibromas in adult patients with neurofibromatosis type 1. The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use, CHMP, and is based on results from KOMET, the largest and only placebo-controlled global Phase III trial in this patient population, which were presented at the 2025 American Society of Clinical Oncology, ASCO, Annual Meeting and published in The Lancet.