Ultrasound Molecular Agent Gets FDA Fast Track Designation for Active Bowel Inflammation with Crohn’s Disease
Phase 2 studies of the BR55 ultrasound contrast agent reportedly demonstrated a 95 percent accuracy in showing the expression of vascular endothelial growth factor receptor 2 (VEGFR2) in bowel segments reflecting active inflammation in patients with Crohn’s disease.
The Food and Drug Administration (FDA) has granted fast track designation to BR55, an emerging molecular ultrasound contrast agent, for the diagnosis of active bowel inflammation in patients with Crohn’s disease.
Targeting the vascular endothelial growth factor receptor 2 (VEGFR2), the injection of BR55 (perfluorobutane/nitrogen lipopeptide-coated microbubbles) achieved
The company maintained that the use of BR55 to detect angiogenesis through non-invasive, radiation-free ultrasound imaging may enhance monitoring and facilitate timely treatment in this patient population.
“The FDA fast track process is aimed at improving the management of patients with serious conditions and filling an unmet medical need, such as the accurate monitoring of disease activity in patients with Crohn's disease,” noted Alberto Spinazzi, M.D., the chief medical and regulatory officer for the Bracco Imaging Group. “This fast track designation supports our goal to get BR55 to the patient earlier and more efficiently."
Bracco Imaging noted that the efficacy and safety of BR55 will be evaluated in forthcoming multicenter, multinational phase 3 studies.
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