FDA approves Allergan's sNDA to update label for DALVANCE (dalbavancin) for injection

Allergan plcJan 21 2016

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).

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.