Koselugo [SELUMETINIB] approved in the EU for plexiform neurofibromas in adults with neurofibromatosis type 1

Koselugo (Selumetinib) Approved in the EU for Plexiform Neurofibromas in Adults with Neurofibromatosis Type 1

Published on: November 2025 | By: ePharma Times

AstraZeneca and Merck & Co., Inc. have announced that Koselugo (selumetinib) has been granted marketing authorization in the European Union for the treatment of adults with Neurofibromatosis Type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PNs).

Why This Matters

NF1 is a rare genetic condition affecting around 1 in 3,000 people worldwide. These tumors can cause pain, disfigurement, and neurological complications. This EU approval marks a critical advancement in targeted therapy options for NF1, expanding treatment accessibility for adult patients across Europe.

Clinical and Patient Impact

Clinical studies demonstrated that selumetinib led to meaningful tumor shrinkage and improved patient outcomes. By targeting the MEK pathway, Koselugo reduces tumor growth and enhances quality of life for individuals living with this complex disorder.

About Selumetinib

Selumetinib is a MEK 1/2 inhibitor developed through a strategic collaboration between AstraZeneca and Merck. It is also being investigated for multiple oncology indications, including thyroid and pediatric cancers.

Future Outlook

With this EU approval, Koselugo strengthens its global footprint as a precision medicine designed to address rare tumor growths. Its success underscores the growing role of targeted therapies and intellectual property advancements in accelerating patient-centric innovation.

e-Pharmatimes

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