Clinical Development for Existing Products
DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension
We believe DEFINITY could improve the accuracy of left ventricular ejection fraction (LVEF) calculations, giving clinicians greater confidence in patient management decisions. We are currently conducting two well-controlled Phase 3 studies (BENEFIT 1 and BENEFIT 2) designed to demonstrate improved accuracy of LVEF measurements with DEFINITY-enhanced echocardiography versus unenhanced echocardiography.
The truth standard in these studies is cardiac magnetic resonance imaging. The studies will be conducted at 20 U.S. sites and will eventually enroll a total of approximately 300 subjects.
We expect to complete enrollment in 2019. With the data from these completed studies, we plan to file a supplemental NDA. and, if approved, we expect commercialization as early as 2020.
Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is 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.
Do not administer DEFINITY® to patients with known or suspected hypersensitivity to perflutren.
IMPORTANT SAFETY INFORMATION
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration [see Warnings and Precautions (5.1)]. Most serious reactions occur within 30 minutes of administration.
- Assess all patients for the presence of any condition that precludes DEFINITY® administration [see Contraindications (4)].
- Always have resuscitation equipment and trained personnel readily available.
In postmarketing use, rare but serious cardiopulmonary or hypersensitivity reactions have been reported during or shortly following perflutren-containing microsphere administration [see Adverse Reactions (6)]. The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions [see Adverse Reactions (6.2)]. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.