27/02/2024
Big news in the world of ! Akili just announced that its Japanese partner, Shionogi & Co., Ltd, has submitted Akili’s digital therapeutic SDT-001 for marketing approval with the Ministry of Health, Labor, and Welfare in Japan.
This marks a significant step forward for the Japanese version of Akili’s AKL-T01, known as ® in the United States. https://www.digitalhealthglobal.com/akili-announces-positive-results-from-shionogis-phase-3-clinical-trial-of-localized-version-of-akilis-endeavorrx-for-pediatric-adhd-patients-in-japan/
EndeavorRx® was previously authorized by the U.S. Food and Drug Administration ( FDA) as the world’s first for improving attentional functioning in pediatric patients aged 8 to 17. Now, with the submission for marketing approval in Japan, the localized SDT-001 could potentially offer an effective and safe treatment option for pediatric patients with ADHD in Japan.
Dr. Scott Kollins, Chief Medical Officer at Akili, emphasized the importance of the latest Japanese clinical trial, stating that it not only validates the efficacy and safety of EndeavorRx but also brings them a step closer to making the product available in Japan. If approved, SDT-001 could fill a gap in pharmaceutical therapies for pediatric ADHD patients in the country.
The submission is based on the positive results of the Phase 3 clinical trial conducted by SHIONOGI in Japan. In this trial, SDT-001 demonstrated statistically significant improvements in ADHD symptoms compared to the control group. Notably, no safety concerns or serious adverse events related to SDT-001 were observed. The sustained symptom improvements after two cycles of SDT-001 use are particularly promising.
This development reinforces the potential global impact of digital therapeutics in improving healthcare outcomes, especially in the realm of pediatric ADHD treatment.
Japanese Product Now Under Review for Nationwide Marketing ApprovalBOSTON--(BUSINESS WIRE)--Akili, Inc. (Nasdaq: AKLI), a leading digital medicine company, today announced that its Japanese partner Shionogi & Co. Ltd has submitted Akili’s digital ...