Akili hopes the FDA pays attention

AKL-T01, Akili’s interactive therapeutic video game, has been languishing in an FDA approval queue for nearly two years following submission of the pivotal Stars-ADHD data at the end of 2017. Publication of the full data in the Lancet Digital Health this week could help with a final push to get the game on the US market. If approved, AKL-T01 would be the first-ever prescription video game. The Stars-ADHD data showed that more of the patients who played the game for 25 minutes a day, five days a week, for a month had a minimum 1.4-point improvement in attention performance compared with those who played a placebo game. Secondary endpoints were more equivocal, however, with the control group seeing similar improvements to the treatment group on some measures. Added to data from the Stars-ADHD Adjunctive study, which was released last month, these figures could add to Akili’s argument for de novo clearance. While there is no guarantee the agency will be won over – and the novelty of the product might be testing the FDA’s regulatory pathways – if it is approved parents will almost certainly take a look at a non-drug alternative for ADHD that can claim an 83% compliance rate.