Otsuka, Proteus refile for FDA approval of digital medicine

Otsuka and Proteus hope to win FDA approval for a sensor-enhanced formulation of Abilify.

Otsuka and Proteus Digital Health have refiled for FDA approval of their digital medicine. The filing is intended to address the human factor testing shortcomings that prompted the FDA to reject the original application.

Officials at the FDA issued a complete response letter for the combination of Otsuka’s antipsychotic Abilify and Proteus’ ingestible sensor 13 months ago. The rejection said Otsuka and Proteus needed to provide more evidence the target population can use the product safely and effectively. Officials also asked for more data on the performance of the product under real-world conditions.

Now, Otsuka and Proteus think they have gathered the data they need to meet the FDA’s demands. The FDA has acknowledged receipt of the resubmission. Officials will now review the filing. Otsuka and Proteus expect the agency to make a decision on the filing in the fourth quarter.


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A positive decision would be a big event for the nascent digital medicine sector and the companies behind the filing. The FDA cleared Proteus’ ingestible sensor. That decision allowed Proteus to embed its miniaturized sensor into inert pills. Adding such pills to a patient’s treatment regimen could help physicians monitor compliance.

The filing with Otsuka was intended to build on this progress. Otsuka has formulated the sensor directly into its antipsychotic Abilify. This frees patients from taking another, sensor-only tablet and provides greater confidence in the data. A positive report from an inert pill implies the patient has taken their medicine. If the technology works as intended, a positive report from a sensor-enabled Abilify tablet guarantees the drug was taken.

Otsuka saw these compliance monitoring capabilities as a way to differentiate Abilify in the face of generic competition. Outcomes for all patients are tied to the extent to which they take their drugs as prescribed. For mental health patients, the nature of their conditions makes compliance harder. This presented Otsuka with an opportunity to deliver better health outcomes using the same drug.

For Proteus, Abilify could act as a proving ground for its technology. The digital pill pioneer has raised more than $200 million but is yet to see the FDA approve a drug featuring its sensor.

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