News
Article
Author(s):
The system is an outpatient procedure that resurfaces the mucosal lining, making it easier for the body to maintain healthy metabolism and blood glucose levels.
The FDA has granted breakthrough device designation to Revita System (Fractyl Health Inc) for the maintenance of weight loss after discontinuation of glucagon-like peptide-1 (GLP-1) medications. The breakthrough device designation grants priority review by the FDA after completion of the REMAIN-1 study, with the potential for early or accelerated decision on reimbursement by the Centers for Medicare & Medicaid Services.1
Image Credit: Iryna - stock.adobe.com
“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,” Harith Rajagopalan, MD, PhD, co-founder and CEO of Fractyl, said in a new release.1
The system is an outpatient procedure that resurfaces the mucosal lining of the duodenum, the first part of the small intestine after the stomach. The duodenum breaks down food into absorbable nutrients, so by targeting the lining, the system makes it easier for the body to maintain healthy metabolism and blood glucose levels.1
The REMAIN-1 trial is a randomized, double-blind study of the system compared with sham in individuals who have lost at least 15% of total body weight on tirzepatide (Zepound, Mounjaro; Eli Lilly). It is being designed as a pivotal study to support the registration filing for Revita and is set to begin in the second half of 2024.2
At the same time as announcing the REMAIN-1 trial, the company also announced the REVEAL-1 study, which is an open-label cohort that will follow a similar population for open-label data updates as the study progresses.2
In 2022, the company announced results of the REVITA-1 and REVITA-2 studies, which established the improvements after 2 years with the device in patients with type 2 diabetes (T2D) and established the efficacy and safety of the device in the same population, respectively.3,4
In the REVITA-1 trial, investigators reported that the mean hemoglobin A1c levels were reduced from 8.5% to 7.5% at 6 months, with the reduction sustained through 24 months. In REVITA-2, investigators established the efficacy for those with T2D with or without non-alcoholic liver disease.3,4
“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,” Rajagopalan said.1
FDA Grants Orphan Drug Designation to MDL-101 for Congenital Muscular Dystrophy Type 1a
