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By Chris Wack
Akili said that its Japanese partner, Shionogi & Co., has submitted Akili’s digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare.
The digital medicine company said SDT-001 is the Japanese, localized version of its AKL-T01, marketed as EndeavorRx the U.S.
EndeavorRx has previously been authorized by the U.S. Food and Drug Administration as the world’s first prescription digital therapeutic for improving attentional functioning in pediatric ADHD patients aged 8 to 17.
The submission for marketing approval in Japan is based on the favorable results of the Phase…