
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 | |||
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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. |