Shionogi files for SDT-001 marketing approval in Japan

Japanese drugmaker Shionogi (TYO: 4507) says it has submitted a marketing approval application for the digital therapeutic app SDT-001, for commercialization and sale in Japan.

SDT-001 is a digital therapeutic app designed for the treatment of pediatric patients with attention deficit hyperactivity disorder (ADHD).

Developed by USA-headquartered digital medicines company Akili Interactive Akili, SDT-001 is the Japanese, localized version of Akili’s AKL-T01, marketed as EndeavorRx in the USA, where it obtained authorization from the US Food and Drug Administration (FDA) in 2020 as the world's first prescription digital therapeutic app for improving attentional functioning in pediatric ADHD patients aged eight to 17. Additionally, Akili, a funded entity of London-listed biotech firm PureTech Health, has acquired the CE mark for distribution in Europe.