Better Therapeutics, a company specializing in software development for the treatment of cardiometabolic diseases, has received FDA authorization for its digital therapeutic, AspyreRx as a treatment for type 2 diabetes (T2D) in patients aged 18 and older.
AspyreRx is a prescription-only digital therapeutic (PDT) that provides cognitive behavioral therapy to address the underlying factors contributing to T2D progression. It offers an evidence-based intervention that helps clinicians and patients make meaningful changes to improve overall health. By integrating with existing disease management programs, AspyreRx provides physicians with a prescription tool to facilitate self-efficacy and promote behavior changes in patients
The FDA’s decision to grant marketing authorization for AspyreRx was based on efficacy and safety data from a randomized controlled trial involving 668 participants. The trial demonstrated clinically significant results, including statistically significant decreases in HbA1c levels, improved cardiometabolic parameters, and positive clinical outcomes associated with greater engagement in cognitive behavioral therapy. Patient engagement and adherence to AspyreRx were high throughout the trial. The FDA’s approval creates a new class of diabetes digital behavioral therapeutic devices.
AspyreRx is expected to launch commercially in Q4 2023. The authorization was based on positive results from a clinical trial, demonstrating significant reductions in HbA1c levels and improved cardiometabolic parameters. Better Therapeutics aims to expand its platform to other related conditions in the future.
Article written by Emma Williams
10/07/2023
Source:
Business Wire
https://www.businesswire.com/news/home/20230710624673/en/Better-Therapeutics-Receives-FDA-Authorization-for-AspyreRx%E2%84%A2-to-Treat-Adults-with-Type-2-Diabetes