The Line Between Drugs and Devices Continues to Blur

Otsuka America Pharmaceutical has signed a collaboration agreement with Magellan Health designed to facilitate access to the first drug-device combination product approved by FDA to track drug ingestion. The agreement creates an opportunity for doctors and adult patients to gather experience in a real-world setting with the Abilify Mycite System, Princeton, NJ-based Otsuka said on Thursday. The Abilify Mycite System is the perfect example of how the line between pharma and medtech continues to blur, which isn't necessarily a bad thing. The product is comprised of Otsuka's oral aripiprazole tablets embedded with an Ingestible Event Marker (IEM) sensor developed by Redwood City, CA-based Proteus Digital Health. But getting the product to the U.S. market hasn't been easy.  Both the Abilify drug and Proteus's sensor were approved and cleared by FDA separately years ago, but the companies needed the agency's blessing to sell a version of Abilify that incorporates the sensor directly into the pill. As MD+DI reported at the time, the companies submitted a new drug application (NDA) to FDA in September 2015 seeking approval for the drug-device combination product, but the agency sent Otsuka and Proteus a complete response letter in April 2016 asking for more information about the combo system. Otsuka and Proteus's luck changed late last year, however, when FDA approved the Abilify Mycite drug-device combination product comprised of Otsukaâ...
Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news