Dalbavancin is used to treat acute bacterial skin and skin structural infections (absssi) caused by Gram-positive bacteria (including methicillin-resistant Staphylococcus aureus). It is the first and only intravenous antibiotic approved for the dual dose regimen of absssi treatment.
Advantages of Dalbavancin:
Edward Cox, MD, MPH, director of the Division of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said: "Today's approval confirms the FDA's commitment to encouraging increased development and approval of new antimicrobial drugs, providing important new treatments for physicians and patients choose."
Dalvance was granted Priority Review as part of its QIDP designation, which provides accelerated review of drug applications. Dalvance's QIDP designation also qualifies for an additional five years of market exclusivity on top of the time already established under the Food, Drug and Cosmetic Act.
The safety and efficacy of Dalvance were evaluated in two clinical trials involving a total of 1,289 adults with ABSSSI. Participants were randomly assigned to receive Dalvance or another antibacterial drug, vancomycin. The results showed that Dalvance was as effective as vancomycin in treating ABSSSI.
Dalbavancin is indicated for the treatment of complicated acute bacterial skin and skin structure infections in adults.
Uses of Dalbavancin:
The drug is a glycopeptide drug, and its outstanding advantage is its long half-life (14 days for dalbavancin), which makes outpatient treatment possible. Its mechanism of action is the same as that of vancomycin and teicoplanin, both of which inhibit the biosynthesis of the cell wall of G+ bacteria. In vivo and in vitro experiments have shown that dalbavancin is effective against G+ bacteria, including methicillin-resistant Staphylococcus aureus and methicillin-susceptible Staphylococcus aureus. Cocci, coagulase-negative staphylococci, streptococci, etc. all have antibacterial activity. At present, dalbavancin has achieved good efficacy in the treatment of catheter-related blood-borne infections and skin and soft tissue infections.
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