Lantheus Announces the FDA Approval of DEFINITY (Perflutren Lipid Microsphere) for Pediatric Patients

DEFINITY is the #1 utilized ultrasound enhancing agent in the U.S. for patients with suboptimal echocardiograms

BEDFORD, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow disease to deliver better patient outcomes, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for DEFINITY (Perflutren Lipid Microsphere) as an ultrasound enhancing agent for use in pediatric patients with suboptimal echocardiograms. This approval represents a significant step forward in pediatric medicine, providing healthcare professionals with a valuable tool to opacify the left ventricular chamber and better identify the left ventricular endocardial border. Currently, DEFINITY is the most utilized, extensively studied, and a trusted diagnostic ultrasound enhancing agent in the U.S.^1-3

“The expanded indication for DEFINITY is a testament to the rigorous research and development efforts undertaken by Lantheus to address unmet medical needs of pediatric patients,” said Jean-Claude Provost, MD, Chief Medical Officer. “We are proud that this approval will extend the benefits of DEFINITY to healthcare professionals who work with these young individuals.”

Clinical studies have substantiated the efficacy and safety of DEFINITY in pediatric patients.

"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,” said Kassa Darge, MD, PhD, Radiologist-in-Chief and Chair of the Department of Radiology at Children’s Hospital of Philadelphia. “This approval will offer a valuable alternative to pediatric cardiologists trying to do imaging work up in challenging pediatric cardiac cases.”

The FDA decision was based on usage data from three pediatric clinical trials conducted with DEFINITY: the Golding study, which evaluated 40 patients, ranging from 1 month to 17 years of age, with significant cardiovascular disorders, including heart transplant, Kawasaki disease or congenital cardiovascular anomaly; the Fine study, which evaluated 36 patients, ranging from 10 to 21 years of age, who had previously undergone a heart transplant; and the Kutty study, a retrospective medical record review of 113 pediatric patients, ranging from 5 to 21 years, who had a diagnosis of known congenital or acquired heart disease or suspected cardiac disease. These studies evaluated the use of DEFINITY in a total of 189 patients (107 (56.5%) were male and 82 (43.5%) were female).^4-6