FDA has accepted the first digital medicine product

Aripiprazole has been combined with an ingestible sensor to create a combination product, Abilify, which has New Drug Application (NDA) acceptance from the Food and Drug Administration (FDA)

Combination products are therapeutic and diagnostic products that combine drugs, devices or biological products.

The combination product, Abilify, treats serious mental illness, includes a Proteus ingestible sensor in a single tablet and could help with patient adherence.

The sensor is expected to help with patient adherence because the Abilify tablet contains an ingestible sensor that communicates with a wearable sensor patch and a medical software application for measuring adherence.

William Carson, president and CEO of Otsuka Pharmaceutical Development & Commercialization, the makers of Abilify, said: “Today, patients suffering from severe mental illnesses struggle with adhering to or communicating with their healthcare teams about their medication regimen, which can greatly impact outcomes and disease progression.

“We believe this new digital medicine could revolutionise the way adherence is measured and fulfill a serious unmet medical need in this population.”