Otsuka and Proteus first to get 'digital medicine' NDA accepted by FDA

The US Food and Drug Administration has determined that the New Drug Application for the combination product of Abilify (aripiprazole) embedded with an ingestible sensor in a single tablet from privately-held US firm Proteus Digital Health, is sufficiently complete to allow for a substantive review and is considered filed as of September 8, 2015.

This is the first time an FDA-approved medication (Abilify from Japanese drugmaker Otsuka Pharmaceutical [TYO: 4768]) has been combined and submitted for approval with a sensor within the medication tablet (the Proteus ingestible sensor) to measure actual medication-taking patterns and physiologic response. This objective information is communicated to the patient - and with the consent of the patient - to his/her physician and/or caregiver. Digital Medicines may enable improved patient medication adherence and better informed physician decision-making to tailor treatment to the patient’s needs.

Could help in patient compliance