大塚製薬が初めてのデジタルメディスンを米国FDAに再申請

Otsuka Pharma And Proteus Digital Health Resubmit Application To FDA For First Digital Medicine
5/23/2017   Schizophrenia, Otsuka, Overseas, Digital medicine

• 大塚製薬と米国プロテウス社が開発したデジタルメディスン（服薬測定ツール）を米国FDAに再申請

• Potential new Digital Medicine consists of Otsuka’s ABILIFY® (aripiprazole) embedded with the Proteus ingestible sensor, for serious mental illness
• Drug/device product digitally records medication ingestion and, with patient consent, shares information with patient’s healthcare providers and selected family and friends
• If approved by the FDA, Digital Medicine would provide patients and physicians with an objective, personalized measure of medication adherence and activity level, as well as self-reported rest and mood1

TOKYO & REDWOOD CITY, Calif.--(BUSINESS WIRE)--Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Proteus Digital Health® (Proteus) today announce that the United States Food and Drug Administration (FDA) has acknowledged receipt of the New Drug Application (NDA) resubmission for the drug-device combination product of ABILIFY® (aripiprazole) embedded with a Proteus ingestible sensor in a single tablet. The NDA resubmission will now be reviewed by the FDA, with an anticipated action date by the agency in the fourth quarter of 2017.

The FDA requested additional information, including further human factors investigations. The goal of human factors testing is to evaluate use-related risks and confirm that individuals can use the system safely and effectively.2

If approved, this Digital Medicine would securely measure patient medication-taking patterns, as well as select physiological data and self-reported behavioral information. This information would help enable individuals along with their healthcare professional team to better manage their serious mental illness. With the patient’s consent, this information could be shared with their healthcare professional team and selected family and friends, with the goal of allowing physicians to be more informed in making treatment decisions that are specific to the patient's needs. This Digital Medicine would be used in the treatment of adults with schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, and as adjunctive therapy for the treatment of major depressive disorder.