New digital medicine system granted first approval

Otsuka Pharmaceutical Co.,Ltd. and Proteus Digital Health have announced that the FDA has granted the first approval of a digital medicine system, comprised of Otsuka’s oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor. Abilify Mycite (aripiprazole tablets with sensor) will be marketed as a drug-device combination product

The Abilify Mycite APP, a smartphone app, used with a compatible smartphone to display information for the patient; and web-based portals for healthcare providers and caregivers that display a summary of aripiprazole ingestion over time. Only functions of the app related to tracking drug ingestion have been approved by the FDA.

Abilify Mycite, an atypical antipsychotic, is indicated in adults for the treatment of schizophrenia, for the treatment of acute manic and mixed episodes, and maintenance treatment of bipolar I disorder as monotherapy, and as adjunctive therapy to lithium or valproate, and the adjunctive treatment of major depressive disorder. Abilify Mycite is intended to track drug ingestion. The ability of Abilify Mycite to improve patient compliance or modify aripiprazole dosage has not been established. The use of Abilify Mycite to track drug ingestion in “real-time” or during an emergency is not recommended because detection may be delayed or not occur.

Otsuka’s approach for the Abilify Mycite system will be conducted in close collaboration with only a select number of health plans and providers, who will identify a limited number of appropriate adults with schizophrenia, bipolar I disorder, or major depressive disorder who may benefit from this new digital medicine system. This limited rollout is purposeful, as having fewer people using the system initially means their prescribers, health plans, and Otsuka can focus on learning from these patients’ experiences. Through ongoing feedback from those using the system every day, Otsuka will further enhance the experience for all prospective users of the Abilify Mycite system. This initial limited rollout will be a crucial step in determining Otsuka’s broader go-to-market plan.

Comment: The question is whether patients with schizophrenia, bipolar I disorder and depression will embrace the new technology or whether payers are willing to reimburse the costs for a high-tech version of a drug that's available as a generic.