- Digital therapeutics developer Akili on Monday received De Novo authorization from the Food and Drug Administration for its video game-based treatment, which is meant to improve attention function in children with attention deficit hyperactivity disorder.
- The prescription-only treatment is indicated for patients between the ages of eight and 12 with primarily inattentive or combined-type ADHD who have demonstrated an attention issue, the FDA specified. Akili's regulatory submission was supported by five clinical studies involving more than 600 children.
- Akili began a limited rollout of the treatment, called EndeavorRx, in April free of charge under a special FDA COVID-19 policy intended to boost access to digital health devices for psychiatric disorders. The company plans to commercialize the product soon but did not specify pricing, and said it aims to help those users who've adopted the product since April to transition to the prescription program.
Monday's decision is a notable milestone in the FDA's regulation of digital therapeutics, products that use software to help prevent, manage or treat a range of health conditions. Akili's product is the first game-based therapeutic FDA has approved for any indication and the first digital therapeutic targeting symptoms associated with ADHD.
Jeff Shuren, head of the FDA's device division, called Akili's device "an important example of the growing field of digital therapy and digital therapeutics."
EndeavorRx works by presenting sensory stimuli and motor challenges to activate neural networks, hopefully improving cognitive function, the company said. The game will be part of a broader treatment protocol that may also include medication, education or clinician-directed therapy. Akili claims the experience makes patients more likely to comply with the treatment regimen.
An Akili-funded study, published in The Lancet Digital Health in February, tested 348 children randomly assigned to a control group or to play Akili's game at home for 25 minutes per day, five days a week for four weeks. At the end of a month with the game-based treatment, Akili reported roughly half of parents observed a "clinically meaningful" difference in their child's day-to-day impairments, and more than two-thirds of parents saw as much after a second month of treatment with the game.
Akili said that no serious adverse events have been linked to its game in any studies so far. The FDA noted the most common adverse events observed when the game was studied were frustration, headache, dizziness, emotional reaction and aggression.
Akili's backers and clinical partners include Amgen Ventures, Shire and Pfizer. The Boston-based company, founded in 2011, has a pipeline of digital treatments in development for autism spectrum disorder, major depressive disorder and multiple sclerosis. The company also has ongoing clinical trials related to traumatic brain injury, ICU delirium and lupus.
Still nascent, the digital therapeutics sector is attempting to gain support from both physicians and insurers.
Some pharmacy benefit managers have launched digital health formularies. For example, Express Scripts in January released its first cohort of 15 products and services, including digital therapeutics and remote monitoring tools, for chronic conditions such as diabetes, hypertension and depression, featuring offerings from Propeller Health, Livongo and SilverCloud. CVS bolstered its own version of a program a few months later.