The FDA has approved Bayer’s Gadavist injection for use with MRI in pediatric patients younger than 2.
The U.S. Food and Drug Administration (FDA) has approved the first gadolinium-based MRI contrast agent for pediatric patients younger than age 2, according to Bayer HealthCare.
Gadavist (gadobutrol) has been indicated to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system, according to Bayer, who manufactures the agent.
The approval grants expanded use to Gadavist, which was first approved in 2011 for use in patient populations older than age 2. The FDA granted the expanded use after a study showed that the pharmacokinetic (PK) and safety profiles in pediatric patients younger than age 2 were similar to that of older children and adults at a standard dose (0.1 mmol/kg), Bayer announced. Gadavist was also approved in June 2014 for MRI of the breast to assess presence and extent of malignant breast disease.
“Until this study, there were limited data regarding the use of gadolinium-based contrast agents in pediatric patients younger than 2 years of age, and there has been a significant need to better understand how they work in our youngest patients,” Dr. Ravi Bhargava, study investigator and pediatric radiologist, University of Alberta, Edmonton, Canada, said in a release.
European Society of Breast Imaging Issues Updated Breast Cancer Screening Recommendations
April 24th 2024One of the recommendations from the European Society of Breast Imaging (EUSOBI) is annual breast MRI exams starting at 25 years of age for women deemed to be at high risk for breast cancer.
New Literature Review Assesses Merits of Cardiac MRI After Survival of Sudden Cardiac Arrest
April 19th 2024While noting inconsistencies with the diagnostic yield of cardiac MRI in patients who survived sudden cardiac arrest, researchers cited unique advantages in characterizing ischemic cardiomyopathy (ICM) and facilitating alternate diagnoses.
Study of Ofatumumab for Multiple Sclerosis Shows 'Profoundly Suppressed MRI Lesion Activity'
April 17th 2024The use of continuous ofatumumab in patients within three years of a relapsing multiple sclerosis diagnosis led to substantial reductions in associated lesions on brain MRI scans, according to research recently presented at the American Academy of Neurology (AAN) conference.