Lantheus Medical Imaging (NSDQ:LNTH) said today it won FDA approval for a label update on its Definity imaging agent which removed a contraindication related to use in patients with a known or suspected cardiac shunt.
The agent is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and improve the delineation of the left ventricular endocardial border, the North Billerica, Mass.-based company said.
The FDA’s decision to remove the contraindication was based on publications and data supporting the safety of the contrast fluid in patients with cardiac shunts, Lantheus said.
“The echocardiography medical and scientific community has long demonstrated the safety of echocardiographic contrast agents through published clinical studies which has supported the removal of the contraindication for Definity in patients with cardiac shunts. This is particularly noteworthy as Definity is the most widely used echocardiography agent in the U.S. with published data supporting its safety profile across multiple care settings and across gender and race in adults, including those age 65 and older. This is an important step toward broader acceptance and appropriate use of echo contrast agents, which can safely and cost effectively provide critical information to help clinicians accurately diagnose and manage patients to achieve better outcomes,” Dr. Neil Weissman of Washington D.C.’s MedStar Health Research Institute
“The label change implemented by FDA is reflective of both the extensive data on contrast agents and the well characterized and stable safety profile of Definity, which has been used to perform more than seven million echocardiography studies. The removal of the cardiac shunt contraindication is expected to provide patients who could benefit from this important diagnostic tool with greater access to Definity when undergoing cardiac ultrasound imaging,” chief medical officer Cesare Orlandi said in a press release.
Last September, Lantheus priced a $40 million offering with funds slated to pay down approximately $55 million of the outstanding principal balance under its senior secured credit facilities.
In August, Lantheus sold its Australian radiopharmacy servicing business to Global Medical Solutions.