The FDA has granted Breakthrough Device Designation (BDD) for Fractyl Health’s Revita System for use in the maintenance of weight loss after discontinuation of GLP-1 drugs. Breakthrough Device Designation will enable priority regulatory review with the FDA upon successful completion of the REMAIN-1 study, as well as the potential for an early or accelerated decision on reimbursement by Centers for Medicare & Medicaid Services (CMS).
“Patients who discontinue GLP-1 drugs need a reliable off-ramp that will allow them to maintain weight loss without having to continue taking these medicines. Breakthrough Device Designation from the FDA validates Revita’s potential for these patients. We believe durable weight maintenance is the single largest unmet need in obesity today, and we believe Revita is one of the only investigational products that is being evaluated in a pivotal study to test its potential to provide sustained weight maintenance,” said Dr Harith Rajagopalan, Co-founder and Chief Executive Officer of Fractyl. “We look forward to reporting data from our open-label study in weight maintenance in the fourth quarter of this year and anticipate a mid-point randomized analysis of the REMAIN-1 pivotal study in Q2 2025. We believe these data will provide further proof that Revita stands alone in the crowded obesity landscape and has the potential to change the treatment paradigm for the majority of patients who want a sustainable solution for their obesity.”
Revita is an outpatient endoscopic procedure that involves resurfacing the mucosal lining of the duodenum, the first part of the small intestine just after the stomach, which is responsible for breaking down food into absorbable nutrients. Revita targets the duodenal lining, which can become thickened by high-fat and high-sugar diets, making it hard for the body to maintain a healthy metabolism and blood glucose levels. By resurfacing and reversing the pathology of the duodenal lining, Revita, if approved, has the potential to become the first disease-modifying therapy that targets a root cause of obesity and T2DM.
GLP-1 agonists have become important in the treatment of diabetes and obesity. Over 40% of patients with diabetes in the US have tried GLP-1s and over 12 million US adults have used them just to lose weight. However, they are not providing patients with sustained solutions to these chronic problems. Discontinuation rates are high due to gastrointestinal side effects, cost, access challenges and other unexplained reasons. Clinical studies have highlighted the risk of substantial weight regain, as much as 66% within one year of discontinuing GLP-1 drugs.
To qualify for a Breakthrough Device Designation, a device technology must address an unmet need and show that it has the potential to provide for a more effective treatment of life-threatening diseases or irreversibly debilitating conditions. The goal of the program is to provide patients and clinicians with timely access to these Breakthrough treatments by accelerating their development, assessment and review while maintaining regulatory standards for pre-market approval.
In prior clinical studies of Revita conducted in people with T2D in the US and EU, pooled analyses of weight data provided evidence to support the potential for durable weight maintenance after a single Revita procedure. Revita is approved in Germany for the treatment of T2D and has both an FDA Breakthrough Device designation in insulin-treated T2D and reimbursement support from the CMS, meaning that CMS will cover routine costs and certain study-related expenses for participants.
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