Allergan Announces FDA Approval of Updated Label for New Dosing Regimen for DALVANCE® (dalbavancin)

- Single-Dose Option Approved for Adult Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) -

Jan 21, 2016, 07:35 ET from Allergan plc

DUBLIN, Jan. 21, 2016 /PRNewswire/ -- Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's supplemental new drug application (sNDA) to update the label for DALVANCE® (dalbavancin) for injection. The expanded label will include a single dose administered as a 30-minute intravenous (IV) infusion of DALVANCE for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible Gram-positive bacteria in adults, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

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DALVANCE is the first and only 30-minute, single-dose treatment option for ABSSSI that delivers a full course of IV therapy, providing an alternative dosing option for physicians.

"Hospitals are facing pressures to reduce hospitalizations and readmissions, while maintaining quality of care and patient outcomes," said David Talan, MD, FACEP, FIDSA, Chairman Emeritus, Department of Emergency Medicine and Faculty, Division of Infectious Diseases, Olive View-UCLA Medical Center. "The single-dose regimen for DALVANCE will allow for delivery of IV antibiotic in 30 minutes in the emergency department and infusion centers, and will provide selected patients the benefit of receiving a complete course of parenteral treatment which may allow for avoiding hospital admission."

Rates of hospitalizations attributed to ABSSSI increased by 17.3 percent from 2005 to 2011, and more than 750,000 hospital admissions were attributed to ABSSSI in 2011 alone. Studies have found the estimated mean cost of an ABSSSI hospitalization in the U.S. is $9,895 with a 4.95 day average length of stay.

The application was based on results from a Phase 3 study, DUR001-303, which compared a single 1500 mg dose of DALVANCE with the two-dose regimen of 1000 mg followed one week later by 500 mg. Data demonstrated the 1500 mg single dose of DALVANCE achieved its primary endpoint of non-inferiority to the two-dose regimen (10% non-inferiority margin) at 48 to 72 hours after initiation of therapy, as determined by a decrease of >20 percent in lesion area relative to the baseline measurement (81.4% vs. 84.2% for the single-dose vs. the two-dose regimen, respectively; difference -2.9; 95% CI: -8.5, 2.8).

"As the first and only IV antibiotic for ABSSSI that delivers a full course of therapy in one 30-minute infusion, DALVANCE will now provide healthcare providers with greater flexibility in treating their patients, offering fewer infusions compared to traditional daily IV infusions," said David Melnick, M.D., Vice President, Clinical Development, Anti-Infectives, Allergan. "Allergan is committed to further research and development of DALVANCE and our entire anti-infective portfolio to help improve clinical outcomes for patients."

DALVANCE was first approved in the U.S. in May 2014 for the treatment of ABSSSI in adults.

DALVANCE is marketed in the European Union as XYDALBA™ (dalbavancin) for injection for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA.

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 two-dose regimen of 1000 mg followed one week later by 500 mg, 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. On May 23, 2014, the FDA approved DALVANCE for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

INDICATION AND USAGE
DALVANCE (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin-susceptible strains).

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 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, and rash.

Hepatic Effects
ALT elevations with DALVANCE treatment were reported in clinical trials.

Clostridium difficile-associated Diarrhea
Clostridium 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 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 patients treated with DALVANCE were nausea (4.7%), headache (3.8%), and diarrhea (3.4%). 

USE IN SPECIFIC POPULATIONS

  • There have been no adequate and well-controlled studies with DALVANCE in pregnant or nursing women.  DALVANCE should only be used if the potential benefit justifies the potential risk in these populations.  
  • In patients with renal impairment whose known creatinine clearance 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.
  • 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 see full prescribing information for DALVANCE at www.dalvance.com.

About 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. The majority of all skin and soft tissue infections in hospitalized patients are caused by streptococci and Staphylococcus aureus, and approximately 59 percent of these S. aureus infections in the U.S. are estimated to be caused by MRSA. Early and effective treatment of ABSSSI is critical to optimize patient recovery and for certain patients may also help to avoid potentially lengthy and costly hospital stays.

About Allergan 
Allergan plc (NYSE:  AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.

Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women's health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world's third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.

With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.

For more information, visit Allergan's website at www.Allergan.com.

Forward-Looking Statement
Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Allergan's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Allergan's current expectations depending upon a number of factors affecting Allergan's business. These factors include, among others, the difficulty of predicting the timing or outcome of FDA approvals or actions, if any; the impact of competitive products and pricing; market acceptance of and continued demand for Allergan's products; difficulties or delays in manufacturing; and other risks and uncertainties detailed in Allergan's periodic public filings with the Securities and Exchange Commission, including but not limited to Allergan's Quarterly Report on Form 10-Q for the quarter ended September 30, 2015 (such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.

CONTACTS: Investors:
                   Lisa DeFrancesco 
                   (862) 261-7152

                   Media:
                   Mark Marmur
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SOURCE Allergan plc



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