US FDA accepts first digital medicine new drug application for Itsuka and Protues Digital Health.
Otsuka Pharmaceutical Co., Ltd. and Proteus Digital Health have announced that the United States Food and Drug Administration has determined that the new drug approval (NDA) for the combination product of ABILIFY embedded with a Protues ingestible sensor in a single tablet is sufficiently complete to allow for a substantive review. It is considered filed as of 8 September, 2015.
This is the first time an FDA-approved medication has been combined and submitted for approval a sensor the medication tablet to measure actual medication-taking patterns and physiologic response. This objective information is communicated to the patient – and with the consent of the patient – to the patient’s physician and/or caregiver. Digital medicines may enable improved patient medication adherence and better inform physician decision making to tailor treatment to the patient’s specific needs.
The ABILIFY tablet contains an ingestible senor that communicates with a wearable senor patch and a medical software application for measuring adherence 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 in adults.
“Today’s patients suffering from severe mental illnesses struggle with adhering to or communication with their healthcare teams about their medication regiment, which can greatly impact outcomes and disease progression,” says William H. Carson, M.D., President and CEO of Otsuka Pharmaceutical Development & Commercialisation, Inc.
He adds: “We believe this new Digital Medicine could revolutionize the way adherence is measured and fulfil a serious unmet medical need in this population. We look forward to continuing working with the FDA throughout the NDA review.”