Technology | Magnetic Resonance Imaging (MRI) | September 06, 2017

FDA Approves Guerbet's Dotarem for Pediatric Patients Younger Than Two Years

MRI contrast agent can now be used to detect disrupted blood brain barrier and/or abnormal vascularity of the central nervous system in youngest patients, including term neonates

FDA Approves Guerbet's Dotarem for Pediatric Patients Younger Than Two Years

September 6, 2017 — Guerbet LLC USA announced that the U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine) for intravenous use with magnetic resonance imaging (MRI) in pediatric patients under two years old, including term neonates. The contrast agent can be used to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system (CNS).

Dotarem was previously approved for this use in patient populations over the age of two.

This supplemental indication fulfills a post marketing requirement, acknowledged when Dotarem was first registered in March 2013, to strictly comply with the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c).

The FDA's review was based on a study showing that at the standard dose (0.1 mmol/kg),1 the pharmacokinetic (PK) and safety profiles in pediatric patients under two were similar to those of older children and adults.

The clinical study enrolled 51 pediatric patients in nine centers, with ages spanning from term neonates to 23 months and with normal renal function. It evaluated 45 pediatric patients for PK profile and safety, including five subjects aged less than one month and nine subjects aged one to three months. It assessed efficacy in a subset of 28 subjects who underwent an MRI examination of brain, spine and associated tissues.

In this pediatric population the observed safety profile of Dotarem was consistent with what has been reported in older populations. In one patient, rash was reported as a moderate adverse event (AE). Serious AEs unrelated to Dotarem were reported in one out of 45 patients. Evaluation of images from contrast-enhanced MRI of the CNS supported extrapolation of CNS efficacy findings reported in adults and older children.

Dotarem is the only macrocyclic and ionic gadolinium-based contrast medium (a kind that provides high molecular stability) available in the United States.

For more information: www.guerbet.com

Read the related article "Recent Trends and Developments in Contrast Media."
 

 

References

1. Dotarem (gadoterate meglumine) US Prescribing Information

Related Content

Videos | Radiation Therapy | May 21, 2019
This is a walk through of the ViewRay MRIdian MRI-guided radiotherapy system installed at ...
Partial Breast Irradiation Effective, Convenient Treatment Option for Low-Risk Breast Cancer
News | Radiation Therapy | May 20, 2019
Partial breast irradiation produces similar long-term survival rates and risk for recurrence compared with whole breast...
AI Detects Unsuspected Lung Cancer in Radiology Reports, Augments Clinical Follow-up
News | Artificial Intelligence | May 20, 2019
Digital Reasoning announced results from its automated radiology report analytics research. In a series of experiments...
360 Photos | Magnetic Resonance Imaging (MRI) | May 17, 2019
This is a dedicated cardiac Siemens 1.5T MRI system installed at the Baylor Scott White Heart Hospital in Dallas.
New Study Evaluates Head CT Examinations and Patient Complexity
News | Neuro Imaging | May 17, 2019
Computed tomography (CT) of the head uses special X-ray equipment to help assess head injuries, dizziness and other...
Miami Cardiac and Vascular Institute Implements Philips Ingenia Ambition X 1.5T MRI
News | Magnetic Resonance Imaging (MRI) | May 17, 2019
Miami Cardiac & Vascular Institute announced the implementation of Philips’ Ingenia Ambition X 1.5T MR, the world’s...
New Phase 2B Trial Exploring Target-Specific Myocardial Ischemia Imaging Agent
News | Radiopharmaceuticals and Tracers | May 17, 2019
Biopharmaceutical company CellPoint plans to begin patient recruitment for its Phase 2b cardiovascular imaging study in...
Managing Architectural Distortion on Mammography Based on MR Enhancement
News | Mammography | May 15, 2019
High negative predictive values (NPV) in mammography architectural distortion (AD) without ultrasonographic (US)...
Icon Launches New Clinical Trial Patient Engagement Platform
Technology | Patient Engagement | May 14, 2019
Icon plc announced the release of its web-based clinical trial patient engagement platform, to provide patients with...