28th Oct 2025 09:36
(Alliance News) - AstraZeneca PLC on Tuesday said Alexion's selective inhibitor Koseluga has been approved in the EU for the treatment of symptomatic, inoperable plexiform neurofibromas, PN, in adult patients with neurofibromatosis type 1, NF 1.
The Cambridge, England-based pharmaceutical company said the approval by the European Commission follows a positive opinion from the Committee for Medicinal Products for Human Use and is based on phase 3 trial data.
Up to 50% of people with NF 1 may develop a type of non-malignant tumour named PN that may affect the brain, spinal cord and nerves. It can grow and become large, painful and can lead to disfigurement and muscle weakness and other debilitating symptoms.
Marc Dunoyer, chief executive officer of Alexion said: "The European Commission approval extends the life-changing potential of Koselugo to adults with NF1 PN in the region, including continuity of care into adulthood. This milestone, along with our pioneering leadership in NF1 PN treatment landscape, embodies Alexion’s unwavering commitment to addressing the unmet needs in the rare disease community. We look forward to bringing Koselugo to those adults in need across Europe as soon as possible."
AstraZeneca shares were 0.2% higher at 12,566.00 pence each on Tuesday morning in London.
By Tom Budszus, Alliance News slot editor
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