LONDON, 24 July (APM) - Otsuka has withdrawn its marketing application in Europe for its digital therapeutic Abilify MyCite, the European Medicines Agency (EMA) said on Friday.
Otsuka had filed the product as a combination of a medicine and a medical device for several indictions: schizophrenia; the prevention of a manic episode in adults who had predominantly manic episodes and whose manic episodes responded to aripiprazole treatment; and for the treatment of moderate to severe manic episodes in bipolar I disorder.
The product, which was approved in the U.S. in 2017 (APMHE 55591
), contains aripiprazole as well as an ingestible sensor for monitoring the medication ingestion.
Once ingested, the sensor is activated in the stomach and transmits data on the date and time of ingestion to a personal monitor.
Otsuka withdrew the application after the EMA informed the company it had some concerns and its provisional opinion was that Abilify MyCite could not have been authorised in patients with schizophrenia and bipolar I disorder.
The EMA said in a document
: "The agency could not assess how well the tablet with the integrated sensor, the patch and the app work together as only limited aspects of usability and technical performance were investigated.
"There was not sufficient evidence that Abilify MyCite is able to reliably measure the intake of the medicine in the target population."
It added: "From a safety point of view, there is a risk the patient could take too many doses because the digital medicine system may not work reliably. In addition, the patch can cause skin and subcutaneous tissue reactions."
The EMA also confirmed Allergan has withdrawn its filing for Rayoqta (abicipar pegol) as a treatment for the eye condition age-related macular degeneration. The decision was announced earlier this week by Allergan's partner Molecular Partners (APMHE 68231