Shionogi files for SDT-001 marketing approval in Japan

27 February 2024
shionogi-big

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.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical