Lantheus Holdings has received approval from the U.S. Food and Drug Administration (FDA) to expand the use of its ultrasound-enhancement drug Definity (Perflutren Lipid Microsphere). This approval allows for the drug’s use during sonograms, where Definity is given to pediatric patients with suboptimal echocardiograms to improve the quality of images. Previously, the drug was only approved for use on adult patients.
Definity is a diagnostic ultrasound enhancing agent that aids healthcare professionals in opacifying the left ventricular chamber and identifying the left ventricular endocardial border in adult cardiac cases. Clinical studies supported the FDA's decision for expanded use by demonstrating the efficacy of Definity in young patients.
Three studies involving 189 individuals, age 1 month to 21 years with various cardiovascular disorders, showed successful left ventricular opacification, with Definity improving the detection of wall motion abnormalities and enhancing ejection fraction determinations, crucial for making an accurate diagnosis. The findings from the studies highlighted the clinical utility of the drug in pediatric patients.
One of the studies demonstrated improved detection of wall motion abnormalities and enhanced ejection fraction determinations in most of the 40 subjects, with success rates of 70% and 80%, respectively. A second study, reviewing records of 113 pediatric patients, found Definity helped identify abnormalities, particularly during stress testing. The third study, focused on heart transplant patients, showed successful use of Definity in left ventricular opacification and myocardial perfusion imaging, with high success rates overall.
"While Definity has long demonstrated its effectiveness in providing better outcomes in adults over the past two decades, this new FDA decision offers a critical diagnostic tool for pediatric heart patients and their families,” Kassa Darge, MD, PhD, radiologist-in-chief at the Department of Radiology at Children’s Hospital of Philadelphia said in a statement. “This approval will offer a valuable alternative to pediatric cardiologists trying to do imaging work-up in challenging pediatric cardiac cases.”
All reported adverse events across all trials were mild, brief and reversible without intervention. While patients did have side effects ranging from palpitations to shortness of breath, it was largely attributed to the cardiac testing and not the drug. However, in rare cases, it has been known to cause adverse reactions and a warning label suggests clinicians have resuscitation equipment and trained personnel readily available whenever Definity is used.
The drug can be used in pediatric ultrasounds and related cardiac tests effective immediately.
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