AstraZeneca's Koselugo receives EU approval

Drugmaker AstraZeneca said on Tuesday that its Koselugo asset has been approved for usage in the European Union for the rare, progressive, genetic condition, plexiform neurofibromas, in adults with neurofibromatosis type 1.

AstraZeneca stated the European Commission's approval follows the positive opinion of the Committee for Medicinal Products for Human Use and was based on results from KOMET, the largest and only placebo-controlled global Phase III trial in this patient population.

NF1 is a rare, progressive, genetic condition usually diagnosed in early childhood, but often progressing into adulthood, that can impact every organ system. Up to 50% of people living with NF1 may develop a type of non-malignant tumour called PN that may affect the brain, spinal cord and nerves.

Koselugo has already been approved in Japan and other countries for the treatment of adult patients with NF1 who have symptomatic, inoperable PN based on data from the KOMET Phase III trial.

Reporting by Iain Gilbert at Sharecast.com