Better Therapeutics, Inc, a leading developer of software for the treatment of cardiometabolic diseases, announced today that the Food and Drug Administration (FDA) has authorised AspyreRx™ (formerly BT-001), a prescription-only digital therapeutic (PDT) for cognitive behavioural therapy in adults aged 18 and older with type 2 diabetes (T2D). AspyreRx underwent FDA review through the De Novo pathway, creating a new category of digital behavioural therapeutic devices for diabetes. The commercial launch of AspyreRx is expected in the fourth quarter of 2023.
"AspyreRx represents a groundbreaking development as it provides an evidence-based intervention to assist clinicians and individuals with type 2 diabetes in addressing the underlying factors contributing to disease progression, going beyond glucose management alone," said Dr. David Kerr, MBChB, DM, FRCP, FRCPE, Director of Digital Health at the Diabetes Technology Society. "Improving self-efficacy is crucial to modern diabetes care, and AspyreRx now offers physicians a prescription tool seamlessly integrated with existing disease management programs to help patients make and sustain meaningful changes for better overall health."
"This regulatory milestone marks a promising future where technology, psychology, and medicine converge to address, for the first time, the behavioural causes of disease in the 37 million T2D patients in the U.S.," said Frank Karbe, CEO of Better Therapeutics. "The De Novo authorization also lays the foundation for potential future growth opportunities. With common underlying factors contributing to the development and progression of cardiometabolic diseases, we plan to expand our PDT platform to address multiple related conditions in the future."
AspyreRx received marketing authorization based on the efficacy and safety data from a randomised controlled trial involving 668 participants, which demonstrated clinically significant results and was published in Diabetes Care.
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