The FDA has approved Allergan's supplemental new drug application to update the label for dalbavancin (Dalvance).
The FDA has approved Allergan’s supplemental new drug application to update the label for dalbavancin (Dalvance).
The expanded label will allow for single-dose treatments administered as a 30-minute IV infusion to treat acute bacterial skin and skin structure infections caused by Gram-positive bacteria in adults.
Dalvance may be used to treat infections caused by methicillin-resistant Staphylococcus aureus.
"Hospitals are facing pressures to reduce hospitalizations and readmissions, while maintaining quality of care and patient outcomes," said David Talan, chairman emeritus of the Department of Emergency Medicine and Faculty at the Division of Infectious Diseases, Olive View-UCLA Medical Center, in a press release. "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."
The FDA approved the application after reviewing results from a phase 3 study, which showed Dalvance’s effectiveness in single-dose form. The drug met its primary endpoint of non-inferiority compared with a 2-dose regimen.
After 48 to 72 hours following therapy, patients saw a decrease of at least 20% in the lesion area compared with the baseline measurement.
The most common adverse effects of Dalvance include nausea, diarrhea, vomiting, headache, rash, and itchiness.
"Allergan is committed to further research and development of Dalvance and our entire anti-infective portfolio to help improve clinical outcomes for patients,” said David Melnick, vice president of Clinical Development for the Anti-Infectives sector of Allergan, in a press release.