Akili's ADHD digital therapy approved in Europe
The European Medicines Agency has approved Akili’s ground-breaking digital therapy for attention deficit hyperactivity disorder (ADHD), which uses a video game to treat the underlying cause of the condition.
The European Commission has granted a CE mark for the game called EndeavorRx, allowing the product to be marketed in Europe although it is not yet available.
Akili’s focus in the near term is a US launch following FDA approval earlier this month, but said it is “exploring expansion opportunities” in Europe.
The company also has a strategic partnership with Shionogi to develop and market the product in Japan and Taiwan.
Akili is one of a group of companies that were founded by PureTech, which retains a controlling stake.
The video game has been years in development and is approved for children between the ages of eight and 12 with certain types of ADHD.
The game is used with other treatments such as clinician-directed therapy, medication and education to treat the common disorder.
The game is designed to target and activate neural systems, by presenting sensory stimuli and motor challenges to improve cognitive functioning.
According to Akili the game targets systems that play a key role in attention function, while using algorithms to personalise the treatment experience for each individual patient.
This enables second by second monitoring of patient progress completing the treatment sessions, and continuously challenges each patient to an optimised level, encouraging patients to improve their performance.
EndeavorRx was cleared based on data from five clinical studies in more than 600 children diagnosed with ADHD.
This included a randomised, controlled study in The Lancet Digital Health journal showing EndeavorRx improved objective measures of attention in children with ADHD.
After four weeks of EndeavorRx treatment, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention.
About half of parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx.
This increased to 68% after a second month of treatment. Improvements in ADHD impairments following a month of treatment with EndeavorRx were maintained for up to a month.
No serious adverse events have been associated with EndeavorRx in any study to date. Some study participants (9.3%) experienced non-serious treatment-related adverse events with EndeavorRx, including frustration, headache, dizziness, emotional reaction, nausea or aggression.
Akili is also developing products for autism spectrum disorder, major depressive disorder, and multiple sclerosis.