The two companies will collaborate to develop and commercialize integrated diabetes self-management solutions.
Astellas Pharma Inc. announced that it has entered into an agreement with Roche Diabetes Care Japan Co., Ltd. for the development and commercialization of Roche Diabetes Care's Accu-Chek® Guide Me blood glucose monitoring system with advanced accuracy as a combined medical product with BlueStar®. BlueStar is an FDA-cleared digital health solution for diabetes patients, developed by Welldoc, Inc. and is currently marketed in the U.S. and Canada. Astellas and Welldoc are jointly developing BlueStar in Japan. In the future, Astellas will aim to obtain regulatory approval and reimbursement as a combined medical product.
The combined medical product solution, which is being developed in Japan, is expected to support patients with managing their diabetes by capturing, storing, and transmitting blood glucose data which is obtained from Roche Diabetes Care's Accu-Chek® Guide Me system and track medication, diet, activity and exercise in Welldoc's BlueStar app. It is also expected to support patients' diabetes self-management with an algorithm designed using AI, and personalized digital coaching messages, focused on building better habits over time. Astellas is responsible for the clinical trials of the combined medical product, which are scheduled to start during 2023.
In Japan, the number of people with diabetes and the number of people with prediabetes is estimated to be approximately 10 million respectively, and there is a substantial unmet medical need in this area. In addition to existing treatments, the development of novel digital solutions that support patients and healthcare professionals in managing these conditions is gaining traction.
This story continues here.