The U.S. Food and Drug Administration today approved Dalvance (dalbavancin), a new antibacterial drug used to treat adults with acute bacterial skin infections (ABSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes by the FDA this past week. The treatment is administered intravenously.
“This approval demonstrates the FDA’s commitment to encouraging increased development and approval of new antibacterial and antifungal drugs to treat serious or life-threatening infections, and provides physicians and patients with important new treatment options,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Dalvance’s safety and efficacy were evaluated in two clinical trials with a total of 1,289 adults with ABSSSI. Participants were randomly assigned to receive Dalvance or vancomycin, another antibacterial drug. Results showed Dalvance was as effective as vancomycin for the treatment of ABSSSI. The most common side effects identified in the clinical trials were nausea, headache and diarrhea. However, it was also found that more of those receiving Dalvance showed elevations in one of their liver enzyme tests