Duodenal mucosal resurfacing granted FDA breakthrough label for weight loss maintenance
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Key takeaways:
- The FDA gave breakthrough device designation for an outpatient duodenal mucosal resurfacing procedure.
- The intervention is being investigated for adults who lost 15% or more weight with tirzepatide.
The FDA granted breakthrough device designation for an endoscopic procedure that resurfaces the duodenum lining to allow for weight maintenance after discontinuation of a GLP-1 receptor agonist, according to an industry press release.
The duodenal mucosal resurfacing intervention (Revita, Fractyl Health) is an outpatient endoscopic procedure that reverses the pathology of the duodenal lining to help people maintain weight loss. The procedure helps reduce the thickening of the duodenal lining that can occur for people eating high fat or high sugar diets.
Breakthrough device designation was granted for the intervention after pooled analysis from previous studies of Revita conducted among people with type 2 diabetes showed durable weight maintenance was achieved following a single procedure. As Healio previously reported, the procedure previously received FDA breakthrough device designation for adults with insulin-treated type 2 diabetes.
The intervention may allow people with obesity to maintain weight loss after discontinuing GLP-1 therapy, according to Harith Rajagopalan, MD, PhD, co-founder and CEO of Fractyl Health.
“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,” Rajagopalan said in the release.
The intervention is currently being investigated in REMAIN-1, a randomized double-blind trial comparing weight loss maintenance with Revita vs. a sham procedure among people who lost at least 15% of their body weight with tirzepatide (Zepbound, Eli Lilly). Initial data from the study are expected later this year and midpoint randomized analysis is expected next year, according to the release.
Reference:
- Fractyl Health announces advancement in weight maintenance pipeline and business updates. Available at: https://ir.fractyl.com/news-releases/news-release-details/fractyl-health-announces-advancement-weight-maintenance-pipeline. Published June 24, 2024. Accessed July 30, 2024.
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