Tali Health 2020, page-1543

https://www.mobihealthnews.com/news/endeavorrx-akilis-video-game-therapeutic-receives-fda-de-novo-clearance

EndeavorRx, Akili's video game therapeutic, receives FDA De Novo clearance
June 15, 2020

The long-awaited decision is the first regulatory authorization for Akili, and the first game-based therapeutic that the FDA has green lit for any condition.

After years of waiting, Akili Interactive has finally received FDA De Novo marketingauthorization for EndeavorRx, its video game digital therapeutic for children aged 8 to 12 years with ADHD.

This is the first game-based therapeutic that the FDA has green lit for any condition,the regulatory agency noted in its announcement. It is also the first authorization for Akili, which has a handful of similar software therapeutic products in its development pipeline.

Previously known as Project: Evo and AKL-T01, the EndeavorRx software treatment isindicated by the agency to improve children's symptoms associated with ADHD,and is intended for use as one component of a broader therapeutic programaddressing these symptoms.

The therapeutic takes the form of a game inwhich users navigate an alien avatar through a course while also responding toon-screen prompts. The app keeps track of movements and can therefore monitorthe user’s behavior and quickly adapt to the player.

“We’reproud to make history today with FDA’s decision," Eddie Martucci, ECO ofAkili, said in a statement. “With EndeavorRx, we’re using technology to helptreat a condition in an entirely new way as we directly target neurologicalfunction through medicine that feels like entertainment. Families are lookingfor new ways to help their children with ADHD. With today’s decision by FDA,we’re excited to offer families a first- of-its-kind non-drug treatment option and take an important first step toward our goal to help all people living withcognitive issues.”

Akili said in the statement that EndeavorRx "will be avilable with aprescription to families soon" as part of the company's Endeavor CareProgram – which alongside the therapeutic app includes a behavior-tracking appfor parents called ADHD Insight, and a direct line to caregiver support services called Akili Assist.

However,a non-prescription form of the digital therapeutic is already being distributed by the company thanks to an emergency policy from the FDA allowing digital products for to be temporarily released temporarily a more formal approval. That rollout provided the first look at the Akili Assist offerings and a general idea of the company's long-touted, pharma-free distribution and commercialization strategy.

WHAT'STHE IMPACT

Tomake its decision, the FDA said that it reviewed trial data from multiplestudies and more than 600 patients – chief among which was the STARS-ADHDpivotal trial that was concluded in late 2017 and published in full just a few months ago.

Acrossthis and other studies, the agency said that it looked for clear improvementsin attention function. No serious adverse events were reported among any of thestudies, according to the FDA. However, frustration, headache, dizziness,emotional reaction and aggression were all reported in the studies as commonadverse events.

Thesedata and the De Novo clearance pave the way for a new modality of ADHDtreatment that clinicians can consider as an alternative, or addition to, drug-basedtreatments and other efforts.

“TheEndeavorRx device offers a non-drug option for improving symptoms associatedwith ADHD in children and is an important example of the growing field ofdigital therapy and digital therapeutics,” Dr. Jeffrey Shuren, director of theFDA’s Center for Devices and Radiological Health, said in a statement. “The FDAis committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”

Beyondthe benefits of EndeavorRx itself, the De Novo clearance opens up a regulatorypathway for upcoming software therapies for ADHD, and more broadly sets aprecedent for game-based products as vetted, evidence-based treatments.

THELARGER TREND

Theregulatory victory has been a long time coming for Akili, which first confirmedthat it was moving forward with an FDA submission for what was then known asProject: Evo back in 2017. The two-and-a-half years since came with relatively few updates from the company, with a couple of notable exceptions.

InJanuary of 2019, Martucci drew a line in the sand separating Akili from the broader trend of digital therapeutics companies partnering with established pharmas to distribute their products. At the time, a representative confirmed that the company was working on "a very different type of commercial model than traditional pharma" for its ADHD therapeutic and following products. That work largely appears to have taken the form of the distribution and support resources available as part of the Endeavor Care Program.

Whenthe company published its pivotal trial in The Lancet Digital Health journalearlier this year, Dr. Anil Jina, chief medical officer at Akili, noted that the company faced some difficulty building an appropriate control for its video game-based treatment, which could have complicated EndeavorRx's case for efficacy. He also acknowledged some "timeline frustration" within the company as it awaited a final decision from the FDA, but still was sympathetic to the regulatory challenges of approving such a product.

TheDe Novo clearance is a feather in the cap for Akili, which was alreadyrecognized within the digital therapeutics space as a frontrunner in video gamemedical treatments, but it's not the only company combining biofeedback andgames to drive behavioral health treatments.

Barcelona-basedBraingaze announced plans to launch its ADHD therapy app in the Chinese market, while another company called ATENTIV has worked to test its ADHD intervention in Singapore and the U.S. Mightier, a Boston Children's Hospital spinout, has also pulled in money from investors for its biofeedback video games designed to help children with emotional regulation.