Otsuka Pharmaceutical and Proteus Digital Health re-submitted an FDA application for their chip-in-a-pill, which combines antipsychotic Abilify with an ingestible sensor made by Proteus.
The FDA is expected to make a decision by the fourth quarter of 2017, the two companies stated in a press release. The re-filing comes about a year after FDA rejected the drug/device combo and asked for additional information, which at the time Otsuka said included performance data and “human factors investigations” — basically testing to evaluate use-related risks and confirm that the system can be used safely and effectively.
“Otsuka and Proteus Digital Health worked together to address the FDA’s questions and provide the additional requested data which, at this point in time, has not been published or presented,” said a spokesperson for the Japan-based drugmaker.
The resubmission of the chip-in-a-pill, one of a handful of palpable industry examples of so-called digital medicine, is a positive sign for the “beyond-the-pill” movement. That phrase, which refers to adding patient-oriented tools and services to older drug and biologic offerings, has flowed off the tongues of pharma execs for years.
Making the transition is another matter. It requires companies to make a series of organizational and cultural changes. Among them, putting data at the head of their decision-making process, as well as reshaping how they manage information.
Developing a digital medicine has required Otsuka to learn how to handle data in real time, an executive from the firm explained during a panel held at the MM&M Transforming Healthcare conference in May in New York.
“It was a huge learning experience for us, something that we weren’t really ready for as a pharma company,” said Animesh Gandhi, Otsuka’s senior director of commercial technology told attendees.
Developing beyond-the-pill offerings “takes pharmas well out of their comfort zones,” noted two analysts from the firm DRG Digital who included the Otsuka/Proteus pairing in a recent blog post on how such offerings are starting to move past the hype.
“Executing truly innovative tools and services is tricky, given the paucity of benchmarks and best practices,” the analysts added. “It’s often a leap into the unknown, but the rewards in an increasingly value-driven world are too great to pass up.”
Abilify, formerly a $6.5 billion drug in the U.S., went off patent in 2015.
The digital form of the medicine includes a patch, or “wearable sensor,” that detects and records the ingestion of the tablet and certain physiological data like activity level. A mobile app displays the data collected by the patch, allowing the wearer to review such things as medication intake and activity level, as well as enter self-reported measures of rest and mood. A web-based portal can display information for the care team.
“Traditionally, pharma is known for processing data in a very batch-oriented way,” Gandhi explained. Patient data is received from the chip-in-a-pill about six times per second. “We had to transform ourselves into a real-time company that has different processes.”