FDA to review whether Definity should be used for stress echo
The FDA has accepted for review Lantheus Medical Imaging’s supplemental new drug application (sNDA) for Definity (perflutren lipid microsphere) injectable suspension for use in stress echocardiography.
Definity is currently indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. With this acceptance, the company said that the FDA will now review the sNDA to determine whether or not to broaden the FDA-approved indication for Definity to include its use with exercise and pharmacologic stress testing.
The safety data included in the submission is based on 22 clinical trials in stress echocardiography with 2,445 patients, according to the North Billerica, Mass.-based Lantheus. A systematic review of the clinical safety of Definity in stress echocardiography identified seven independent peer-reviewed publications on the safety of contrast agents, including Definity (DMP 115) during 110,299 stress echocardiograms. A review of the safety data from these trials showed that the safety profiles of contrast echocardiography and non-contrast echocardiography were similar, the company reported.
Definity is currently indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. With this acceptance, the company said that the FDA will now review the sNDA to determine whether or not to broaden the FDA-approved indication for Definity to include its use with exercise and pharmacologic stress testing.
The safety data included in the submission is based on 22 clinical trials in stress echocardiography with 2,445 patients, according to the North Billerica, Mass.-based Lantheus. A systematic review of the clinical safety of Definity in stress echocardiography identified seven independent peer-reviewed publications on the safety of contrast agents, including Definity (DMP 115) during 110,299 stress echocardiograms. A review of the safety data from these trials showed that the safety profiles of contrast echocardiography and non-contrast echocardiography were similar, the company reported.