Better Therapeutics Submits De Novo Request to U.S. FDA for BT-001 Investigational Prescription Digital Therapy for 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.
Excerpt from the Press Release:
SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address the root causes of cardiometabolic diseases, today announced that it has submitted a de novo classification request to the U.S. Food and Drug Administration (FDA) seeking marketing authorization for BT-001, its potentially first-in-class digital therapeutic designed to use CBT to treat Type 2 Diabetes (T2D) in patients 18 years and older.
“Submitting this de novo request is not just a major milestone for our company but an important moment for patients, providers and payers. As the first digital therapeutic submitted to the FDA for the treatment of type 2 diabetes, BT-001 marks a new kind of treatment paradigm with the potential to address the root causes of this and other cardiometabolic diseases,” said Mark Berman, MD, Chief Medical Officer of Better Therapeutics. “By providing people with convenient, personalized treatment rooted in decades of behavioral science, we aim to help them take back control and live healthier lives, instead of relying on increasingly costly pharmaceutical treatments that place undue burden on patients and fail to address the behavioral root causes of disease.”
This submission follows positive results from the BT-001 pivotal trial, the largest randomized control study ever conducted of a digital therapeutic to evaluate glycemic response in T2D. The trial met both its primary and secondary endpoints demonstrating statistically and clinically meaningful reductions in A1c over the current standard of care, even as control group patients increased use of blood sugar lowering medications.
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