First digital medicine system approved by FDA
About the author
Dipl.-Kauffrau Heike Kielhorn-Schönermark
Founder and Managing Director
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
Fax: +49 511 64 68 14 18
The product, Abilify MyCite, is a collaboration between the Japanese pharmaceutical company Otsuku Pharmaceuticals and the US company Proteus Digital Health. It includes the drug aripiprazole, which has been approved since 2002, embedded with an Ingestible Event Marker (IEM) sensor as well as a patch attachable to the body receiving the sensor signal of each tablet after contact with gastric acid, and the evaluation app.
Aripiprazole is an atypical neuroleptic, primarily applied to treat patients with schizophrenia, but also in affective disorders. Especially in this field of psychiatric disorders, the regular intake of medication is important and a traceability of drugs can be very useful.
The data sovereignty of the medical data therein are maintained by the patient. The attending physician or family members may access the drug intake via a platform, however, the patient must provide the data and authorize third party access. This configuration is a common model in dealing with data in digital medicine. Thus, patients can evaluate whether they see any benefit in the digital product for themselves. In this way, application of digital medicine can lead to empowerment of patients. However, clinical trials that examine the actual impact on compliance are also needed - in consequence of this highly application-oriented requirement for the trials, a trial within the health insurance system could be suitable (read also our blog about evolution of clinical trials).
On the regulatory side, there is an interesting development with the approval of this product. Abilify MyCite is a novel combination of pharmaceutical and medical products, in which both are inextricably linked. Since market access and reimbursement for medical devices and pharmaceutical products are regulated very differently in many European countries, it remains to be seen in which regulatory framework such a product will be assessed.
BY Heike Kielhorn-Schönermark, MBA, Founder and Managing Director, SKC Beratungsgesellschaft mbH
Sources:
Jama Network: Digital pill gains approval
FDA News Release: FDA approves pill with sensor that digitally tracks if patients have ingested their medication