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.

Seeing stars: Akili's pivotal trial data
Endpoint AKL-T01 Control p value
API type A: improvement >1.4 points (primary endpoint) 47% 32% 0.0058
API type B: post-intervention score ≥0 11% 4% 0.033
Brought into normative range of one or more objective measurements of attention 36% 21% 0.0027
ADHD-rating scale (improvement ≥2 points) 74% 73% 0.77
ADHD-rating scale (≥30% reduction)* 24% 19% 0.23
Impairment rating scale 48% 37% 0.049
Clinical global impressions (≤2 at postintervention) 17% 16% 0.86
Clinical global impressions (1 at post-intervention) 1% 1% 0.96
API = Attention performance index. *Post-hoc analysis.  Source: The Lancet Digital Health.

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