Dive Brief:

• Digital therapeutics developer Akili Interactive Labs received De Novo authorization Monday from FDA for its video game-based treatment 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, FDA specified. The regulatory submission was supported by five clinical studies covering 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 as appropriate.

Dive Insight:

Monday's decision is a notable milestone in FDA's regulation of digital therapeutics, a class of evidence-based products that use software to help prevent, manage or treat a range of health conditions. Akili's product marks the first game-based therapeutic FDA has OK'd for any indication, the first digital therapeutic targeting symptoms associated with ADHD, and the first product the company is able to commercialize.

Center for Devices and Radiological Health Director Jeff Shuren 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 systems and thereby improve cognitive functioning, the company said. The game will be part of a broader treatment protocol that may also include medication, education, or clinician-directed therapy. The experience makes patients more likely to comply with the treatment regimen, Akili contends.

Akili's technology also uses algorithms to personalize the treatment. Improvement in attention function is measured by computer-based testing. 

An Akili-funded prospective, randomized study, published in The Lancet Digital Health in February, assessed 348 patients 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, but 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 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.

The nascent digital therapeutics sector is still navigating how to gain backing from physicians and payers.

Some PBMs 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, asthma and depression, featuring offerings from Propeller Health, Livongo and SilverCloud. CVS bolstered its own version of a program a few months later.

Monday's De Novo authorization creates a new classification for Akili and other companies to bring digital therapy devices for ADHD, defined as software intended to provide therapy for ADHD or any of its individual symptoms as an adjunct to clinician supervised treatment, to market via 510(k) submissions. As a Class II device, FDA also laid out a series of special controls related to labeling, clinical testing and software verification, validation, and hazard analysis.

The EndeavorRx nod is the tenth De Novo authorization FDA has awarded so far this year, according to the agency's database.