AspyreRx, formerly BT-001, provides cognitive behavioral therapy to patients 18 years or older with type 2 diabetes. The prescription-only digital therapeutic (PDT) underwent review through the FDA de novo pathway. The company submitted an FDA de novo request in September 2022 for the therapeutic. Earlier this year, it suggested that authorization would come at some point in 2023.
San Francisco-based Better Therapeutics says the authorization creates a new class of diabetes digital behavioral therapeutic devices. The company expects to launch AspyreRx in the fourth quarter of this year.
“This regulatory milestone signals a promising future where technology, psychology, and medicine converge to address for the first time the behavioral causes of disease for the 37 million patients living with T2D in the U.S.,” said Frank Karbe, CEO at Better Therapeutics. “This De Novo authorization also provides a foundation for potential future growth opportunities. Given cardiometabolic diseases share common underlying factors that contribute to their development and progression, we intend to expand our PDT platform to multiple related conditions in the future.”
David Kerr, director of digital health at the Diabetes Technology Society, called AspyreRx a “a game-changer.”
“The cornerstone of modern diabetes care is helping to improve self-efficacy and AspyreRx now provides a prescription tool for physicians that seamlessly integrates with existing disease management programs to help patients make and sustain meaningful changes to improve their overall health,” Kerr said.
How Better Therapeutics got its digital therapeutic authorized
AspyreRx received its marketing authorization based on safety and efficacy data from a randomized controlled trial of 668 subjects.
The trial met its primary and secondary endpoints, showing statistically significant decreases in HbA1c levels. It compared users of its PDT to a control group receiving standard of care and a control app. Results sustained and improved between day 90 and 180 of the trial. This suggests AspyreRx’s ability to deliver meaningful, durable blood sugar reductions in a complex array of type 2 diabetes patients.
Additionally, one in two subjects achieved a mean A1c reduction of 1.3% after 180 days of use. On average, subjects using Better Therapeutics’ PDT saw a range of cardiometabolic improvements. Those included improved fasting blood glucose, reduced systolic blood pressure, reduced weight, improved mood, improved quality of life scores, lower medication utilization and fewer diabetes-related risks compared to control.
Patient engagement and adherence came in at 94% at day 90 with 81% still engaged at day 180.
“Our team has dedicated eight years to developing this treatment and we are grateful for the thousands of patients who have used our platform and for the many clinicians who have guided us to this point,” said Dr. Mark Berman, chief medical officer at Better Therapeutics. “We are immensely proud of this milestone and believe AspyreRx holds the promise to enhance access to care for the diversity of the patient population, empowering individuals to live healthier lives.”
