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First ‘Digital Medicine’ Approved, Slow Rollout Planned

 
• By Mandy Jackson and Elizabeth Orr

FDA has approved Abilify MyCite, a treatment for some psychiatric conditions that integrates a drug with a sensor that records when the medication is taken. The goal is to track medication compliance. It is an important regulatory milestone for the nascent field of digital medicine, but many questions about the market remain.

Otsuka Pharmaceutical Co. Ltd. is moving forward with a slow, measured launch of their first-in-class “digital medicine” for psychiatric conditions after a challenging FDA approval process that the companies say ultimately improved the product's usability.

US FDA announced Nov. 13 that it has approved Abilify MyCite (aripiprazole tablets with sensor), developed with partner Proteus International PLC. It’s the first combination product to integrate a...

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