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First digital medicine approved in the US

The antipsychotic drug has a built-in digital tracking sensor


The FDA has approved Otsuka and Proteus Health’s Abilify MyCite, a pill with an embedded sensor that monitors whether patients have ingested the medication.

It’s the first time that a medicinal product with built-in digital tracking has been approved by the US regulator, and could be useful for some patients who find it difficult to comply with drug treatment, according to director of the FDA’s psychiatric products division Mitchell Mathis.

“The FDA supports the development and use of new technology in prescription drugs and is committed to working with companies to understand how technology might benefit patients and prescribers,” he said.

Abilify MyCite is the latest iteration of antipsychotic blockbuster Abilify (aripiprazole) to reach the market, and is approved for the same indications as its parent products - schizophrenia, bipolar I disorder and for use as an add-on treatment for depression in adults.

The product takes the form of an aripiprazole tablet with an ingestible sensor developed by Proteus that sends messages to a wearable patch that in turn transmits dosing information to an app on the patient’s mobile phone. Patients can also authorise their carers and physician to access the information through a web-based portal. The system can also collect data on activity levels, as well as self-reported rest and mood status.

“This information allows the opportunity for an open dialogue with the patient,” commented John Kane, chair of psychiatry at the Barbara Zucker School of Medicine at Hofstra/Northwell in New York City. “Until now, pharmacologic therapy for serious mental illness has been missing a systematic approach to objectively track and signal that a patient has taken their drug.”

The FDA turned down the first filing for the product last year, asking for more data on potential risks and confirmation that patients can use the technology effectively. Proteus’ ingestible sensor has already been approved as a standalone device in both the US and Europe.

For now Proteus and Otsuka are not discussing the pricing of the new product and says they will carry out test marketing to try to gauge demand prior to a full roll-out. The company has also been working with Novartis on using the technology to assist compliance with anti-rejection drugs given after organ transplantation.

In a statement, the FDA cautioned that labelling for Abilify MyCite “notes that the ability of the product to improve patient compliance with their treatment regimen has not been shown”, and recommends against using the technology to track ‘real-time’ ingestion or during an emergency “because detection may be delayed or not occur”.

Article by
Phil Taylor

14th November 2017

From: Regulatory



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