Fractyl Health's Revita Gains FDA Breakthrough Designation for Obesity Weight Maintenance After GLP-1 Drug Discontinuation

Fractyl Health, Inc., a company specializing in metabolic therapeutics, announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Revita System. This designation is aimed at assisting in the maintenance of weight loss following the cessation of GLP-1 drugs. The Breakthrough Device Designation is designed to facilitate an expedited review process by the FDA and could lead to quicker decisions on reimbursement by the Centers for Medicare & Medicaid Services (CMS) once the REMAIN-1 study is successfully concluded.

Revita is an outpatient endoscopic procedure that focuses on resurfacing the mucosal lining of the duodenum, the initial part of the small intestine just beyond the stomach. The duodenum plays a crucial role in breaking down food into nutrients that can be absorbed. High-fat and high-sugar diets can thicken this lining, making it challenging for the body to maintain a healthy metabolism and blood sugar levels. By resurfacing the duodenal lining, Revita aims to reverse these pathological changes, potentially making it the first therapy to address the root causes of obesity and type 2 diabetes (T2D).

Obesity is a widespread and complex condition often associated with multiple cardiometabolic complications, including T2D. Although GLP-1 agonists have significantly impacted the treatment of diabetes and obesity, they do not provide a long-term solution. Over 40% of diabetes patients in the U.S. have used GLP-1s, and more than 12 million adults have tried them for weight loss alone. However, these drugs have high discontinuation rates due to various factors such as gastrointestinal side effects, cost, and accessibility issues. Studies have shown that patients can regain as much as 66% of the weight lost within one year of stopping GLP-1 drugs.

To receive a Breakthrough Device Designation, a device must address an unmet medical need and demonstrate the potential to offer more effective treatment for life-threatening or severely debilitating conditions. This program aims to accelerate the development, assessment, and review of such devices while maintaining regulatory standards for pre-market approval.

Dr. Harith Rajagopalan, Co-founder and Chief Executive Officer of Fractyl, emphasized the importance of providing patients who discontinue GLP-1 drugs with a sustainable solution to maintain weight loss. He believes that durable weight maintenance is the most significant unmet need in obesity treatment today. According to Rajagopalan, Revita is one of the few investigational products currently undergoing pivotal studies to evaluate its potential for long-term weight maintenance. Data from an open-label study is expected in the fourth quarter of this year, with a mid-point randomized analysis of the REMAIN-1 pivotal study anticipated in the second quarter of 2025. Rajagopalan expressed confidence that these findings would further validate Revita's unique position in the field of obesity treatment.

Previous clinical studies of Revita in the U.S. and EU involving patients with T2D have shown promising results. Pooled analyses indicated that a single Revita procedure could support durable weight maintenance. In Germany, Revita is approved for treating T2D and has received both Breakthrough Device Designation from the FDA for insulin-treated T2D and reimbursement support from CMS, covering routine costs and certain study-related expenses for participants.

Fractyl Health's primary product candidate, Revita, is based on the company's insights into the role of the gut in obesity and T2D. The device is designed to remodel the duodenal lining through hydrothermal ablation, addressing abnormal nutrient sensing and signaling mechanisms that contribute to metabolic disease. Revita has received a CE mark in Europe and reimbursement authorization in Germany for T2D treatment. In the U.S., Revita is for investigational use only. A pivotal study, REVITALIZE-1, is ongoing in the U.S. and Europe for T2D patients inadequately controlled on other glucose-lowering agents. Additionally, the REMAIN-1 study is underway to assess Revita's effectiveness in weight maintenance post-GLP-1 drug discontinuation, with data expected in late 2024 and mid-2025. 

Fractyl Health is committed to transforming the treatment of metabolic diseases from chronic symptomatic management to durable, disease-modifying therapies that target the root causes at the organ level. The company is headquartered in Burlington, MA.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!