FDA Accepts First-Ever Digital Medicine NDA

Otsuka Pharmaceutical and Proteus Digital Health announced last week FDA acceptance of their first-of-its-kind digital medicine NDA combining Abilify with a digital tracking mechanism.

The drug/device combination embeds an ingestible Proteus sensor in Otsuka’s blockbuster antipsychotic Abilify (aripiprazole), allowing data to be sent to a wearable patch that records individualized treatment information. The information — including ingestion patterns, adherence, rest, step count, body posture and other biometric data — is then sent to the patient’s mobile phone and, with consent, to doctors or caregivers.

Otsuka hopes to boost drug therapy compliance with the combination. “By increasing overall patient compliance rates even modestly, health outcomes can be improved for many and healthcare costs can be reduced significantly,” spokeswoman Kimberly Whitefield said.

Abilify was approved by the FDA in 2007. The Proteus ingestible sensor and wearable patch were cleared for marketing in 2012. Otsuka anticipates a PDUFA decision date of April 26.

Otsuka estimates that poor patient compliance costs the U.S. between $100 billion and $300 billion in avoidable healthcare annually. — Victoria Pelham