Better Therapeutics Requests FDA Marketing Approval For Its Prescription Digital Therapy For Type 2 Diabetes

Better Therapeutics, Inc., which develops prescription digital therapeutics (PDTs), submitted a de novo classification request to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for a PDT that uses cognitive behavioral therapy (CBT) to treat adults with type 2 diabetes. Submission follows completion of first-in-class trial demonstrating significant improvements in A1c reduction with investigational therapy targeting the root causes of type 2 diabetes.

The PDT, currently referred to as BT-001, was tested in a clinical trial to evaluate the PDT’s effect on the participants’ glycemic response. The PTD outcomes were compared to a . . .