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Akili Granted FDA Clearance for ADHD Treatment
Akili Granted FDA Clearance for ADHD Treatment.
About this update from Puretech Health Plc
[{"type":"text","content":"\n \n \n RNS Number : 0347Q\n PureTech Health PLC\n 16 June 2020\n \n \n \n \n 16 June 2020 \n \n \n PureTech Health plc\n \n \n \n \n \n PureTech Founded Entity Akili Announces FDA Clearance of EndeavorRxTM for Children with ADHD, the First Prescription Treatment Delivered Through a Video Game\n \n \n \n \n \n Shown to improve attention function, EndeavorRx is backed by data from five clinical studies, including a prospective, randomised controlled trial\n \n \n \n \n \n EndeavorRx is the second product developed from PureTech's unique R&D model to achieve FDA clearance\n \n \n \n \n \n \n \n PureTech Health plc\n \n \n (LSE: PRTC) (\"PureTech\"\n \n or the \"Company\"), a clinical-stage biotherapeutics company dedicated to discovering, developing and commercialising highly differentiated medicines for devastating diseases, \n is pleased to announce that its Founded Entity, Akili, has been granted\n \n US Food and Drug Administration (FDA) clearance for \n EndeavorRxTM (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). Delivered through a captivating video game experience, EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD,\n \n who have a demonstrated attention issue. See full indication below. \n Persistent attention issues have a significant impact on the daily lives of millions of people. Attention impairments are a key component of ADHD for many children. \n \n \n \n \n \n Daphne Zohar, founder and chief executive officer of PureTech said: \"The FDA clearance of EndeavorRx is a tremendous milestone as it represents an entirely new class of medicine for children and their families. EndeavorRx is the first digital therapeutic intended to improve symptoms associated with ADHD, and it is also the first game-based therapeutic to be granted marketing authorisation by the FDA for any type of condition. EndeavorRx is now the second product developed from PureTech's unique R&D model to receive FDA clearance and is further validation of our approach to inventing, identifying, and advancing truly innovative medicines for patients.\"\n \n \n \n \n \n E\n ndeavorRx was granted clearance based on data f...