Lantheus Announces the Approval of DEFINITY® (Perflutren Lipid Microsphere) by China’s NMPA
DEFINITY is the leading diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms
With this approval, DEFINITY is indicated in
“We congratulate our partner, CR Double-Crane, on the successful approval of DEFINITY in
The efficacy of DEFINITY administration during echocardiography was assessed in a prospective independent blinded evaluation of non-contrast and DEFINITY contrast images for left ventricular endocardial border delineation (i.e., assessment of left ventricular endocardial segments) and left ventricular opacification in more than 600 subjects. These subjects came from clinical trials that enrolled similar patient populations with suboptimal echocardiography images, study designs and imaging procedures. The confirmatory study conducted in
The safety data included several clinical trials that evaluated the use of activated DEFINITY in 1,716 patients (1063; 61.9% were male and 653; 38.1% were female) with a mean age of 56.1 (range 18 to 93). Of these, 144 (8.4%) patients had at least one treatment-related adverse reaction. Among the 1,716 DEFINITY patients studied, serious adverse events were reported in 30 patients. None of the serious adverse events were considered related to DEFINITY administration. Adverse events appeared within minutes (1 - 15 min) of the drug administration and were of moderate intensity, resolving usually without treatment within minutes or hours after onset. Sub-analyses by age, gender and race were performed. The overall incidence of adverse events was similar for the <65-year age group and the ≥65-year age group, similar in males and in females, and similar among all racial or ethnic groups. The most frequent adverse events were reported for the central and peripheral nervous system (3.1%), body as a whole (2.4%) and gastrointestinal system (1.8%). The most frequently occurring treatment-related adverse experiences were headache (2.3%), back/renal pain (1.2%), ﬂushing (1.1%) and nausea (1.0%).
About DEFINITY in
DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension (activated) is approved in the
DEFINITY is not approved in the
DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension
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 lipid microsphere or its components.
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.
In post-marketing 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.
Please see accompanying full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions, on www.definityimaging.com.
With more than 60 years of experience in delivering life-changing science,
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by their use of terms such as “will” and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved. Readers are cautioned not to place undue reliance on the forward-looking statements contained herein, which speak only as of the date hereof. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) our dependency on Double-Crane’s ability to successfully launch DEFINITY as a commercial product in
1DEFINITY® (Package Insert),
2Data on file,
3DRG Echo Monthly Monitor 2022
Vice President, Investor Relations
Senior Director, Corporate Communications
Source: Lantheus Holdings, Inc.