Better Therapeuticss Submits De Novo Request To FDA To Market Type 2 Diabetes Medicine

(RTTNews) - San Francisco-based digital therapeutics company, Better Therapeutics, Inc (BTTX) has submitted a de novo request for the marketing authorization of BT-001 to the US FDA. According to the company, it can be the first-in-class digital therapeutics to use cognitive behavioral therapy to treat Type 2 Diabetes patients.

Mark Berman, MD, Chief Medical Officer of the company, said, "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 cardio-metabolic diseases."

Berman added that the treatment will help the patients move away from the traditional pharmaceutical treatment methods. Previously, Better also reported a sustainable and durable result of the pivotal trial of the medicine on a large control group.

If permitted, BT-001 will be the first prescription solution for CBT delivery to the patients suffering from Type 2 Diabetes through their own devices. The company is also looking at exploring options of treating cardiometabolic conditions like nonalcoholic fatty liver, hypertension, and hyperlipidemia through CBT.