An Akili Interactive Case Study – The FDA has Entered the Game


The Medullan team attended the 4th annual DTx West Conference, held virtually this year on February 23-25, 2021. This year’s focus was digital therapeutics and how the industry can “accelerate digital therapeutics into the hands of patients.”  In a 4 part series, our team recorded critical takeaways from select sessions of the conference.


Part 2: An Akili Interactive Case Study – The FDA has Entered the Game


On Day 2, the session – “An Akili Interactive Case Study – The FDA has Entered the Game”, presented by Dr. Anil Jina, Chief Medical Officer at Akili Interactive, walked the audience through the process of obtaining FDA approval for Endeavor Rx, the world’s first prescription video game therapeutic. With the company relatively fresh from their recent FDA approval, they were in an excellent position to take a look back to highlight some of their high and low points throughout the ordeal. In this session, Dr. Jina presented his impressions and lessons learned from the process and outlined several aspects of Akili’s future strategy.


Key insights from the session were:


Obtaining de novo clearance for a digital therapeutic is a long and time-consuming road. This process for Endeavor Rx took Akili about two years from start to finish. Other DTx products’ implications are to engage with regulators early and often in the process and be prepared for the long haul. By coordinating with the FDA from the onset, they better understand the clinical outcomes needed to be addressed to achieve approval.

Dr. Jina advised looking for predicate devices or technology before attempting a de-novo clearance. However, as he explained for Endeavor, Akili was going to be a pioneer in this space, and so they had no choice but to seek this type of clearance. Predicates can be used to support a 510(k) submission, which can reduce time to market by demonstrating the new device or technology is as safe and effective (i.e. substantially equivalent) to a previously legally marketed device or technology.

Evidence of clinical efficacy is required for digital therapeutic solutions. The gold standard for measuring clinical effectiveness is Randomized Control Trials (RCTs), necessitating careful consideration for setting up a control group when the therapy is a video game. Initially, Akili was hesitant to create a “sham” game for the early trials, opting for word search exercises instead. Dr. Jina commented how many patients from the control group even believed that they were in the study’s intervention arm. However, for future studies, Akili eventually invested in another video game to act as the sham in the clinical trials for Endeavor Rx.


In Summary

In future studies, Dr. Jina shared that Akili plans to compare Endeavor Rx to a usual care patient cohort so that Akili can assess Endeavor Rx benefits compared to the ‘gold standard’ of care for ADHD. Additionally, having gone through the Endeavor process alone, Akili is now open and considering pharma companies’ collaborations to ease the regulatory and commercial burden.

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