Better Therapeutics files for FDA approval of new type of digital therapy for diabetes

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• Better Therapeutics (NASDAQ:BTTX) said it filed a de novo classification request to the U.S. Food and Drug Administration (FDA) seeking approval of digital device BT-001 to use cognitive behavioral therapy (CBT) to treat type 2 diabetes (T2D) in patients 18 years and older.
• According to the FDA the De Novo request provides a marketing pathway to classify new medical devices for which there is no legally marketed predicate device.
• The submission included data from a trial which showed statistically and clinically meaningful reductions in A1c (blood sugar levels) over the current standard of care, even as control group patients increased use of blood sugar lowering drugs, the company said in a Sept. 22 press release.
• Better Therapeutics noted that if authorized, BT-001 would be the first validated, prescription solution for delivering CBT to patients with T2D at scale, from their digital devices.
• The investigational therapy is delivered via software which is aimed to help patients address the underlying causes of T2D by making sustainable behavioral changes, the company added.
• BTTX -1.06% to 1.87 premarket Sept. 22