NORTH CHICAGO, Ill.,
July 23, 2021 /PRNewswire/ -- AbbVie
(NYSE: ABBV) today announced that the U.S. Food and Drug
Administration (FDA) approved DALVANCE® (dalbavancin) for the
treatment of acute bacterial skin and skin structure infections
(ABSSSI) in pediatric patients from birth. DALVANCE is the first
single-dose option administered as a 30-minute intravenous (IV)
infusion for the treatment of ABSSSI caused by designated
susceptible Gram-positive bacteria in pediatric patients, including
infections caused by methicillin-resistant Staphylococcus
aureus (MRSA).
"Serious infections in children can be difficult to treat and
the impact of ABSSSI among children is significant, as these
infections often require IV antibiotics, resulting in
hospitalization," said Margaret
Burroughs, medical director, infectious diseases, AbbVie.
"This pediatric approval for DALVANCE as a single-dose provides a
meaningful contribution to the treatment of children and infants
with ABSSSI."
ABSSSI are bacterial infections of skin and associated tissues
primarily caused by Gram-positive pathogens, including
Staphylococcus aureus and Streptococcus pyogenes.
While ABSSSI are common, these infections can be serious and may be
life-threatening. ABSSSI are a significant source of morbidity in
children. Cutaneous abscesses and cellulitis are the predominant
types of skin infections evaluated by pediatricians.[1] In
the United States, ABSSSI lead to
3 million pediatric health care visits per year, placing a heavy
burden on the health care system.1
This approval is based on results from a multicenter,
open-label, actively controlled clinical trial evaluating DALVANCE
in pediatric patients from birth to less than 18 years of age with
ABSSSI and 3 pharmacokinetic studies. In the ABSSSI study, the
safety and efficacy of DALVANCE was evaluated along with
intravenous vancomycin (for methicillin-resistant Gram-positive
infections), or intravenous oxacillin or flucloxacillin (for
methicillin susceptible Gram-positive infections). Participants
were randomized 3:3:1 to receive single-dose DALVANCE, 2-dose
DALVANCE, or comparator. The primary objective of the study was to
evaluate the safety and tolerability of DALVANCE. The trial was not
powered for a comparative inferential efficacy analysis. To
evaluate the treatment effect of DALVANCE in the ABSSSI pediatric
trial, an analysis was conducted on 183 patients with ABSSSI in the
Modified Intent-to-Treat (mITT) population, which included all
randomized patients who received any dose of study drug and had a
diagnosis of ABSSSI caused by Gram-positive organism(s). This
analysis evaluated an early clinical response at 48 to 72 hours
based on achieving a ≥ 20% reduction in lesion size compared to
baseline and no receipt of rescue antibacterial therapy for
children 3 months and older. The 5 patients in the age group birth
to less than 3 months of age were not included in the efficacy
analyses since they were enrolled with expanded inclusion criteria
and only received the single-dose DALVANCE regimen. The
proportion of patients with an early clinical response was 97.3%
(73/75) in the DALVANCE single-dose arm, 93.6% (73/78) in the
DALVANCE 2-dose arm, and 86.7% (26/30) in the comparator arm.
Results from the clinical trial in pediatric patients show that
the safety findings of DALVANCE in pediatric patients were similar
to those observed in adults.
The approved recommended dosage regimen of DALVANCE in pediatric
patients with a creatinine clearance of 30 mL/min/1.73m2 and above is a single-dose
regimen based on the age and weight of the pediatric patient.
About DALVANCE
DALVANCE for injection is a second-generation, semi-synthetic
lipoglycopeptide, which consists of a lipophilic side-chain added
to an enhanced glycopeptide backbone. DALVANCE is the first and
only IV antibiotic approved for the treatment of ABSSSI with a
single dose regimen of 1500 mg and two-dose regimen of 1000 mg
followed one week later by 500 mg in adults, and a single dose
regimen based on age and weight in pediatric patients, each
administered over 30 minutes. DALVANCE demonstrates bactericidal
activity in vitro against a range of Gram-positive bacteria,
such as Staphylococcus aureus (including
methicillin-resistant, also known as MRSA, strains) and
Streptococcus pyogenes, as well as certain other
streptococcal species.
INDICATION AND USAGE
DALVANCE® (dalbavancin) for injection is indicated
for the treatment of adult and pediatric patients with acute
bacterial skin and skin structure infections (ABSSSI) caused by
designated susceptible strains of Gram-positive microorganisms:
Staphylococcus aureus (including methicillin-susceptible and
methicillin-resistant isolates), Streptococcus pyogenes,
Streptococcus agalactiae, Streptococcus dysgalactiae,
Streptococcus anginosus group (including S.
anginosus, S. intermedius, S. constellatus) and Enterococcus
faecalis (vancomycin-susceptible isolates).
To reduce the development of drug-resistant bacteria and
maintain the effectiveness of DALVANCE and other antibacterial
agents, DALVANCE should be used only to treat or prevent infections
that are proven or strongly suspected to be caused by susceptible
bacteria.
IMPORTANT SAFETY INFORMATION
Contraindications
DALVANCE is contraindicated in
patients with known hypersensitivity to dalbavancin.
Warnings and Precautions
Hypersensitivity Reactions
Serious hypersensitivity
(anaphylactic) and skin reactions have been reported with
glycopeptide antibacterial agents, including DALVANCE. Exercise
caution in patients with known hypersensitivity to glycopeptides
due to the possibility of cross-sensitivity. If an allergic
reaction occurs, treatment with DALVANCE should be
discontinued.
Infusion-related Reactions
Rapid intravenous infusion
of DALVANCE can cause reactions, including flushing of the upper
body, urticaria, pruritus, rash, and/or back pain.
Hepatic Effects
ALT elevations with DALVANCE treatment
were reported in clinical trials.
Clostridioides difficile-associated
Diarrhea
Clostridioides difficile-associated diarrhea
(CDAD) has been reported with nearly all systemic antibacterial
agents, including DALVANCE, with severity ranging from mild
diarrhea to fatal colitis. Evaluate if diarrhea occurs.
Development of Drug-resistant Bacteria
Prescribing
DALVANCE in the absence of a proven or strongly suspected bacterial
infection or a prophylactic indication is unlikely to provide
benefit to the patient and increases the risk of the development of
drug-resistant bacteria.
Adverse Reactions
The most common adverse reactions in
adult patients treated with DALVANCE in Phase 2/3 trials were
nausea (5.5%), headache (4.7%), and diarrhea (4.4%). The most
common adverse reaction that occurred in more than 1% of pediatric
patients was pyrexia (1.2%).
Use in Specific Populations
- There are no adequate and well-controlled studies with DALVANCE
use in pregnant or nursing women. The developmental and health
benefits of breastfeeding should be considered along with the
mother's clinical need for DALVANCE and any adverse effects on the
breast-fed child from DALVANCE or from the underlying maternal
condition.
- In patients with renal impairment whose known creatinine
clearance (CLcr) is less than 30 mL/min and who are not receiving
regularly scheduled hemodialysis, the recommended regimen of
DALVANCE is 1125 mg, administered as a single dose, or 750 mg
followed one week later by 375 mg. No dosage adjustment is
recommended for patients receiving regularly scheduled
hemodialysis, and DALVANCE can be administered without regard to
the timing of hemodialysis. There is insufficient information
to recommend dosage adjustment for pediatric patients younger than
18 years of age with CLcr less than 30 mL/min/1.73m2.
- Caution should be exercised when prescribing DALVANCE to
patients with moderate or severe hepatic impairment (Child-Pugh
Class B or C) as no data are available to determine the appropriate
dosing in these patients.
Please click here for the Full Prescribing
Information.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie on
Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statements
Some statements in this
news release are, or may be considered, forward-looking statements
for purposes of the Private Securities Litigation Reform Act of
1995. The words "believe," "expect," "anticipate," "project" and
similar expressions, among others, generally identify
forward-looking statements. AbbVie cautions that these
forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially from those
indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, failure to realize
the expected benefits from AbbVie's acquisition of Allergan plc
("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2020 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
1
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4166563/
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