Digital Therapeutics

The time has come for apps to treat disease. In 2010, the world's first app recognized for its therapeutic effect on diabetes was approved in the U.S. as a "therapeutic app”. It was an event that opened a new page in the battle between humanity and diseases. The 21st century is also known as the age of AI, and AI and other digital content are making significant contributions to the diagnosis and treatment of diseases.
Digital content for the purpose of diagnosis and treatment of diseases must be used by the appropriate person in the appropriate manner, and is therefore subject to review and approval as a medical device by the regulatory authorities in each country. In Japan, a new category of “Software as a Medical Device (SaMD)” was created by a legal amendment in 2014, establishing an approval process by the Ministry of Health, Labor and Welfare.

Eisai and Digital Therapeutics

Eisai is taking on the challenge of developing therapeutic SaMD (digital therapeutics) in the areas of neurology and oncology. Pharmaceuticals exert their therapeutic effects on diseases through the direct action of active ingredients in the body. Digital therapeutics, on the other hand, deliver therapeutic benefits by bringing about changes in patient behavior through digital content such as apps. Based on these characteristics, we are not only conducting early-stage studies of digital therapeutic treatment concepts, but also working to identify promising seeds of digital therapeutics from around the world from a scientific standpoint. We are currently working on developing digital therapeutics to more quickly and appropriately treat the side effects associated with the use of anticancer drugs.

Developing Digital Therapeutics

Eisai promotes hhc activities, in which 1% of our working hours are spent with patients and their families, and our corporate culture reflects the insights and thoughts we gain from these activities into our products. Likewise, in digital therapeutics, we aim to maximize the effectiveness of treatment and benefits to patients by devising products with an easy-to-understand and easy-to-use user interface, which serves as a point of contact with patients, through hhc activities.
In order to obtain approval from regulatory authorities as a digital therapy, it is generally necessary to demonstrate an objective therapeutic efficacy. We use our experience and expertise gained from drug development to develop strategies to deliver our digital therapeutics to patients as quickly as possible.

The Future of SaMD

There is a category of SaMD, including digital therapeutics, that is intended for prevention. Although digital therapeutics that can fulfill "prevention" do not yet exist, we believe that the day is not far off when they will be realized along with technological innovations such as wearable devices and AI that continue to evolve. For example, prevention might be achieved by obtaining user data from smartphones and other mobile devices, scoring the risk of developing a disease, and suggesting measures to reduce that risk. In addition to the development of products that treat diseases after they have occurred, we would also like to aim for products that can also prevent diseases in the mid- to long-term.