Better Therapeutics has received marketing authorisation from the US Food and Drug Administration (FDA) for its prescription-only digital behavioural therapeutic device, AspyreRx.
AspyreRx (previously BT-001) is intended for delivering cognitive behavioural therapy to type 2 diabetes (T2D) patients aged 18 years and above.
The authorisation has been granted for the device based on the efficacy and safety data of a randomised controlled study, which assessed 668 participants.
According to the company, the trial achieved its primary and secondary endpoints by demonstrating statistically significant reductions in HbA1c levels when compared with a control group receiving standard of care and a control app.
After 180 days of use, one in two people attained a mean A1c reduction of 1.3%, in the study.
On average, subjects using BT-001 witnessed a range of cardiometabolic enhancements, including reduced systolic blood pressure, reduced weight, improved quality of life scores and improved fasting blood glucose.
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Better Therapeutics CEO Frank Karbe said: “This regulatory milestone signals a promising future where technology, psychology and medicine converge to address for the first time the behavioural causes of disease for the 37 million patients living with T2D in the US.
“This De Novo authorisation 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.”
The company plans to commercially launch the new digital therapeutic device in the fourth quarter of this year.
More than 35 million people in the US have T2D, according to the Centers for Disease Control and Prevention (CDC), which is over 10% of the US population.