AstraZeneca's Koselugo Gets European Nod To Treat Children With Multisystem Genetic Disorder

·1 min read
  • European Union has approved AstraZeneca plc's (NASDAQ: AZN) Koselugo to treat children with neurofibromatosis type 1 and plexiform neurofibromas.

  • Neurofibromatosis type 1 is characterized by soft lumps on and under the skin and skin pigmentation.

  • The approval was granted by the European Commission for children aged three and above and was based on positive results from the SPRINT Stratum 1 Phase 2 trial.

  • The trial, sponsored by the National Cancer Institute's Cancer Therapy Evaluation Program, showed an overall response rate of 66% in pediatric patients and reduced the size of inoperable tumors in children, reducing pain and improving quality of life.

  • Koselugo has already been approved in the U.S. to treat neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas on patients aged two years and older.

  • Price Action: AZN shares are down 0.29% at $58.14 during the premarket trading session on the last check Tuesday.

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