EMA's CHMP gives Proteus positive opinion for use of ingestible to measure drug adherence in clinical trials

Ingestible sensor pill, patch and iPad app--Courtesy of Proteus

The regulatory road for Proteus Digital Health has been a long and hard one. For while it received a CE mark in Europe for its ingestible sensor system to detect medication adherence in 2010. It has taken until now for the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) to offer its stamp of approval for use of the system in clinical trials.

Similarly in the U.S., Proteus and Otsuka are awaiting the first FDA approval of a drug to integrate the system, which embeds the ingestible sensor into Otsuka's Abilify to treat severe mental illnesses including schizophrenia. They made the submission to that agency last September. Earlier last year, FDA specifically cleared the system for measuring medication adherence. But it first received de novo clearance from the agency way back in 2012.

The Proteus system includes an ingestible sensor that sends signals to a wearable patch after it reaches the stomach, and the patch then records and time-stamps the information, sending it back to a mobile phone or Bluetooth device.

The sensor also records other patient metrics such as rest, body angle and activity patterns, giving a better picture of what a patient is doing while they're taking the drug and potentially improving adherence. It can be taken alongside a particular medication or actually incorporated into a pill, as is the case with Abilify.

CHMP, which serves a function similar to FDA regulatory panels by offering early opinions to guide later regulatory decision-making, concluded in its review that the Proteus ingestible system can be used in clinical studies as a novel biomarker.

"The CHMP agrees in considering the use of the Proteus technology as a qualified method for measuring adherence in clinical trials," the agency concluded in its report released on Feb. 16. An earlier draft of the opinion was released last August after which it received public responses.

Regardless of the regulatory heel-dragging on this novel technology, Proteus has announced a few major advancements for it this year.

The first was in early January with an announcement of the first healthcare system, South Lake Tahoe, CA-based Barton Health, to adopt use of Proteus technology to monitor medication use for long-term chronic conditions--with the first being hypertension. The second came later that month with the announcement that Proteus is among the 8 founding partners for high-profile Virtual Care Clinic being developed by The University of Southern California Center for Body Computing.

- here is the CHMP opinion