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
The Golding study, together with supportive data from the Fine
and Kutty studies, demonstrate that left ventricular opacification
with DEFINITY (cumulative doses ranging from 6 µL/kg to 20 µL/kg)
is successful in pediatric patients and that ultrasound contrast
provides important information to guide management in such
patients. In the Golding study, both the ability to detect wall
motion abnormalities and the ability to perform ejection fraction
determinations were improved in the majority (70% and 80%,
respectively) of subjects. The Kutty and Fine studies each reported
successful left ventricular opacification in all participants. In
the Kutty study, wall motion and/or myocardial perfusion wall
motion abnormalities were identified in 13 (11.5%) of the patients
(all identified during stress testing), and the number of left
ventricular segments visualized improved from 13 ± 1 per patient
without contrast to 16 ± 1 segments per patient with contrast
across all patients. The Fine study identified regional wall motion
abnormalities detected in three patients (8.3%, n=36), and
demonstrated successful myocardial perfusion imaging in 32 patients
(88.9%), with imaging in some patients complicated by movement
and/or insufficient heart rate factors.4-6
All reported adverse events across all trials were mild, brief
and reversible without intervention. Specifically, the Golding
study reported no AEs among study participants; the Fine study
reported that 33% of patients experienced mild AEs (palpitations,
headache, nausea and shortness of breath) attributed to stress test
procedures and not as a result of DEFINITY administration; and the
Kutty study reported 11% of patients experienced AEs with no
differences between DEFINITY and those patients who did not receive
DEFINITY in frequencies of adverse events (chest/back/neck pain,
headache, fatigue, dizziness, shortness of
breath).4-6
About DEFINITY® DEFINITY
Vial for (Perflutren Lipid Microsphere) Injectable Suspension is an
ultrasound enhancing agent approved for use in patients with
suboptimal echocardiograms (see Indications and Important Safety
Information below and find full Prescribing Information at
www.definityimaging.com).6 DEFINITY is the most utilized,
extensively studied and a trusted ultrasound enhancing agent with
more than 20 years in the market.1-3
DEFINITY® Vial
for (Perflutren Lipid Microsphere) Injectable
Suspension
INDICATIONSDEFINITY® is indicated, after
activation, for use in adult and pediatric patients with suboptimal
echocardiograms to opacify the left ventricular chamber and to
improve the delineation of the left ventricular endocardial
border.
CONTRAINDICATIONSDEFINITY® is
contraindicated in patients with known or suspected
hypersensitivity to perflutren lipid microsphere or its components,
such as polyethylene glycol (PEG) [see Warnings and Precautions
(5.2) and Description (11)].
IMPORTANT SAFETY INFORMATION
WARNING: Serious Cardiopulmonary
ReactionsSerious cardiopulmonary reactions,
including fatalities, have occurred uncommonly during or following
perflutren-containing microsphere administration. 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
[see Warnings and Precautions
(5.1)].
|
In post-marketing use, rare but serious cardiopulmonary or
hypersensitivity reactions have been reported during or shortly
following perflutren and PEG-containing microsphere administration
[see Adverse Reactions (6)]. The risk for these reactions may be
increased among patients with unstable cardiopulmonary conditions
and/or with pre-existing PEG hypersensitivity [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 conditions.
Patients with sickle cell disease may be at higher risk of
painful crisis and DEFINITY® should be administered with
caution.
Healthcare providers and pediatric specialists are encouraged to
review the updated prescribing information for DEFINITY, when
available, to incorporate the expanded indication into their
clinical practice.
Please see accompanying full Prescribing Information for
DEFINITY®, including
boxed WARNING regarding serious
cardiopulmonary reactions, on www.definityimaging.com.
About Lantheus Lantheus is the leading
radiopharmaceutical-focused company, delivering life-changing
science to enable clinicians to Find, Fight and Follow disease to
deliver better patient outcomes. Headquartered in Massachusetts
with offices in New Jersey, Canada and Sweden, Lantheus has been
providing radiopharmaceutical solutions for more than 65 years. For
more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary
StatementsThis 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 “aim,” “will” and other similar terms. Such forward-looking
statements are subject to risks and uncertainties that could cause
actual results to materially differ from those described in the
forward-looking statements. Readers are cautioned not to place
undue reliance on the forward-looking statements contained herein,
which speak only as of the date hereof. Lantheus 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 Lantheus’ actual results to
materially differ from those described in the forward-looking
statements are discussed in Lantheus’ filings with the Securities
and Exchange Commission (including those described in the Risk
Factors section in Lantheus’ Annual Report on Form 10-K and its
Quarterly Reports on Form 10-Q).
1Data on file, Lantheus.2Embase and Medline Search, May 2018;
Data on file, Lantheus.3©2021 Millennium Research Group, Inc. All
rights reserved. Reproduction, distribution, transmission or
publication is prohibited. Reprinted with permission.4Fine, N. M.,
et. al (2021). Myocardial Contrast Echocardiography for Cardiac
Allograft Vasculopathy: Feasibility of Real-Time Myocardial
Contrast Echocardiography to Detect Cardiac Allograft Vasculopathy
in Pediatric Heart Transplant Recipients. Journal of the American
Society of Echocardiography.5Kutty, S., et al (2016). Safety and
Efficacy of Cardiac Ultrasound Contrast in Children and Adolescents
for Resting and Stress Echocardiography. Journal of the American
Society of Echocardiography. 6 DEFINITY® (Package Insert), North
Billerica, MA, Lantheus Medical Imaging, Inc.
Contacts:
LantheusMark KinarneyVice President, Investor
Relations 978-671-8842ir@lantheus.com
Melissa DownsSenior Director, External Communications
646-975-2533media@lantheus.com
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