AstraZeneca given EU approval for use of Koselugo in children

Drugmaker AstraZeneca said on Tuesday that its Koselugo drug had been approved for use in children with neurofibromatosis type 1 and plexiform neurofibromas across the European Union.

AstraZeneca highlighted that the approval of Koselugo in patients with NF1, a debilitating genetic condition where tumours develop on the nerve sheaths, made it the first medicine to have been approved to treat the condition in the EU.

The FTSE 100-listed firm stated that the approval by the European Commission was based on positive results from a Sprint Stratum 1 Phase II trial sponsored by the National Institute of Health's National Cancer Institute cancer therapy evaluation program, which showed that Koselugo reduced the size of inoperable tumours in children, reducing pain and improving quality of life.

Dave Fredrickson, vice President of AZN's oncology business, said: "As the first medicine approved in the EU for patients with neurofibromatosis type 1, Koselugo has the potential to transform the way plexiform neurofibromas are managed and treated.

"The Sprint data showed that Koselugo not only shrank tumours in some children, but also reduced pain and improved their quality of life. This significant milestone was made possible thanks to our research partners, the National Cancer Institute, the Neurofibromatosis Therapeutic Acceleration Program, the Children's Tumor Foundation, the patient community and every child, parent and doctor involved in the clinical trial."

As of 0820 BST, AstraZeneca shares were down 0.74% at 8,345.72p.