Research & Development
AstraZeneca and MSD's Koselugo gets EU approval in children with NF1
22 June 2021 -

Biopharmaceutical company AstraZeneca plc (STO:AZN) (LON:AZN) (Nasdaq:AZN) reported on Tuesday that Koselugo (selumetinib) has been granted conditional approval in the European Union for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric patients with neurofibromatosis type 1 (NF1) aged three years and above.

NF1 is a genetic condition that affects one in 3,000 individuals worldwide. In 30-50% of people with NF1, tumours develop on the nerve sheaths (plexiform neurofibromas) and can cause clinical issues such as disfigurement, motor dysfunction, pain, airway dysfunction, visual impairment and bladder or bowel dysfunction.

Approval by the European Commission was based on positive results from a Phase II trial which showed that Koselugo reduced the size of inoperable tumours in children, reducing pain and improving quality of life. This is the first approval of a medicine for NF1 PN in the EU.

AstraZeneca and Merck & Co Inc (NYSE:MRK), known as MSD outside the US and Canada, formed a global strategic oncology collaboration in July 2017 to co-develop and co-commercialise Lynparza, the world's first PARP inhibitor, and MEK inhibitor Koselugo (selumetinib), for multiple cancer types.

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