PureTech's Akili gets CE-mark for 'EndeavourRx'

Biotherapeutics company PureTech Health said its founded entity Akili had received a CE-mark for ‘EndeavorRx treatment for attention deficit hyperactivity disorder (ADHD).

The FTSE 250 company said that, while EndeavorRx was not yet available in Europe, the CE-mark would enable Akili to market EndeavorRx in European Economic Area (EEA) member countries.

It said ADHD is one of the most common psychiatric disorders in childhood, with almost 5% of children in Europe diagnosed with the disorder.

The CE-mark followed 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, PureTech said Akili was exploring expansion opportunities in Europe as part of its global strategy.

In March 2019, Akili announced a strategic partnership with Shionogi to develop and commercialise EndeavorRx in Japan and Taiwan.

“Akili's European marketing authorisation today is an important milestone for families in Europe looking to help their children with ADHD,” said PureTech founder and chief executive officer Daphne Zohar.

“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 research and development engine have now received marketing authorisation in both the US and Europe.”

At 0840 BST, shares in PureTech Health were down 0.19% at 269.5p.