DALVANCE® (dalbavancin) Receives FDA Approval to Treat Acute Bacterial Skin and Skin Structure Infections in Pediatric Patients

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/

SOURCE AbbVie

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