FDA agrees to review first digital drug filing with Otsuka and Proteus Digital Health's single tablet combining Abilify, ingestible sensor

The FDA accepted a marketing application for a product combining Otsuka's schizophrenia therapy Abilify (aripiprazole) and an ingestible sensor from Proteus Digital Health in a single tablet, the companies announced Thursday. The drugmakers noted that the filing marks the first time approval is being sought for an FDA-approved drug embedded with a sensor to measure medication-taking patterns and physiologic response. William Carson, CEO of Otsuka's development and commercialisation unit, said "we believe this new digital medicine could revolutionise the way adherence is measured and fulfil a serious unmet medical need in this population."

The companies indicated that when the drug-device product is ingested, it transmits a signal after reaching the stomach to a wearable Proteus patch that records and dates information received by the sensor and also collects other patient metrics, including rest, body angle and activity patterns. Patients then receive the data via a mobile phone or Bluetooth-enabled device, and may also consent to share it with their doctors and caregivers, who can view the information through secure web portals.

"Digital medicines have the potential to move healthcare beyond the proven efficacy of a medicine, to understand the real-world effectiveness of a therapy for each individual," stated Proteus CEO Andrew Thompson. He added that "this means that medicines could be tailored to each of us to reflect our unique medication-taking patterns, lifestyle and daily health choices." Thompson suggested the FDA's acceptance of Otsuka and Proteus' application is a milestone in the development of digital medicine, saying "this is the opening of a new regulatory pathway that allows the pharmaceuticals industry to combine its medical innovation with innovation in software."

Following its initial approval in 2012, Proteus' ingestible sensor technology was recently expanded by the FDA as an aid to monitoring drug adherence. Thompson noted that Proteus also has a partnership with Novartis to develop digital medicines, while other drugmakers have expressed interest in collaborating with his company.

Otsuka and Proteus entered into a global agreement in 2012 to develop and promote new drugs based on Otsuka's pharmaceutical products and Proteus' digital health feedback system that incorporates its sensor-based technologies.

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