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FDA approves dalbavancin for serious skin infections
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The FDA today announced the approval of dalbavancin for adults with serious skin infections caused by certain gram-positive organisms.
Dalbavancin (Dalvance, Durata Therapeutics) is intended for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria such as Staphylococcus aureus, including strains that are methicillin-susceptible and methicillin-resistant, and Streptococcus pyogenes.
“Today’s approval demonstrates the FDA’s commitment to encouraging increased development and approval of new antibacterial drugs, providing physicians and patients with important new treatment options,” Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
Edward Cox
Dalbavancin is the first Qualified Infectious Disease Product — a designation given to antibacterial or antifungal human drugs intended to treat serious or life-threatening infections under the Generating Antibiotic Incentives Now title of the FDA Safety and Innovation Act — to receive FDA approval.
The approval is based in part on results of two clinical trials which evaluated dalbavancin vs. vancomycin in 1,289 adults with ABSSSI. Researchers found dalbavancin was noninferior to vancomycin.
Nausea, headache and diarrhea were the most commonly observed adverse events in both trials. More patients assigned dalbavancin experienced liver enzyme elevations, for which dosage adjustments are recommended on the label.
The FDA approved dalbavancin as part of its priority review program.