FDA approves 1st medicine with digestible sensor — 4 key notes

The FDA approved Otsuka Pharmaceutical's and Proteus Digital Health's Abilify Mycite system, an aripiprazole tablet with a digestible sensor to monitor drug ingestion and treat mental illness among others.

Here's what you should know:

1. The system includes the Abilify Mycite, the Mycite patch, the Mysite app and a web-based portal for providers.

2. Abilify Mycite tracks ingestion. The pill was designed to improve patient compliance. The sensor will transmit to the physician and user when the pill was taken.

3. Otsuka is rolling out the system in limited quantities so providers, health plans and the company can "[learn] from these patients' experience."

4. Otsuka will take the data from the limited rollout to enhance the system before launching a broader go-to-market plan.

Otsuka Pharmaceutical's President Tatsuo Higuchi said in a release, "This approval marks a potentially transformative juncture in our more than 25 years of experience in the field of mental health therapies. We remain committed to making a difference for individual patients and their care team by helping address the challenge of objectively measuring medication ingestion."

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