Approval of CE Mark enables the marketing of EndeavorRx in European Economic Area member countries. Delivered through a video game experience, EndeavorRx has been studied across five clinical studies including a large, randomised controlled trial.
LONDON: PureTech Health’s founded entity, Akili Interactive has received a Conformité Européenne (CE) Mark for EndeavorRx (AKL-T01) as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in paediatric patients with Attention Deficit Hyperactivity Disorder (ADHD).
While EndeavorRx is not yet available in Europe, the CE Mark enables Akili to market EndeavorRx in European Economic Area (EEA) member countries. ADHD is one of the most common psychiatric disorders in childhood and nearly five per cent of children in Europe are diagnosed with the disorder.
The CE Mark follows last week’s US Food and Drug Administration (FDA) decision, which made EndeavorRx the first FDA-cleared prescription treatment delivered through a video game and the first game-based therapeutic to be granted marketing authorisation by the FDA for any type of condition. With a near-term focus on launching the EndeavorRx prescription treatment in the US, Akili is exploring expansion opportunities in Europe as part of its global strategy. In March 2019, Akili announced a strategic partnership with Shionogi & Co., Ltd. to develop and commercialise EndeavorRx in Japan and Taiwan.
Daphne Zohar, founder and chief executive officer of PureTech said: “Akili’s European marketing authorisation today is an important milestone for families in Europe looking to help their children with ADHD. This is on the heels of the exciting news of Akili’s FDA clearance last week and Gelesis’ receipt of a European CE Mark for Plenity® earlier this month. We are so proud that two products developed from our unique R&D engine have now received marketing authorisation in both the US and Europe.”
“Following our recent FDA clearance, the CE Mark is another important milestone for Akili,” said Anil Jina, MD, chief medical officer of Akili. “This approval provides a path for the future expansion into Europe and will allow us to offer a new non-drug treatment option to families of children living with ADHD.”
Akili is combining scientific and clinical rigour with the ingenuity of the tech and entertainment industries to challenge the status quo of medicine. Akili has pioneered the development of video game-based digital medicine to improve cognitive function. Akili’s flagship product, EndeavorRx, is a prescription digital treatment to address inattention in children with attention deficit hyperactivity disorder (ADHD).
