Akili’s therapeutic computer game snares world-first approval

Welcome to the era of the prescription video game. The FDA has cleared for market the first ever such project – EndeavorRx, designed by Akili to treat children aged children 8 to 12 with attention deficit hyperactivity disorder in conjunction with medication or educational programmes. Analysts from Jefferies, covering Akili’s parent company Puretech, believe the approval validates Akili’s cognitive interference processing platform, which is also used with the phase II projects AKL-T02 for paediatric autism and AKL-T03 for multiple sclerosis. The analysts peg peak sales of EndeavorRx at $300m in the US alone, reflecting the appeal to parents of a non-drug treatment for their children, as well as the game’s decent showing in its pivotal trial. But these are unproven technologies as far as their commercial model is concerned; exactly how they will be paid for and whether reimbursement is obtainable are hurdles yet to be jumped. Still, the clearance of EndeavorRx via the FDA’s de novo pathway creates a new class of digital therapeutics which should smooth the path of future prescription computer games. EndeavoRx will soon be available to download from various app stores, Akili says, along with a related mobile tracking app called Akili Care.