FDA approves drug to treat MRSA skin infections
The Food and Drug Administration has approved Dalvance (dalbavancin), an antibacterial drug used to treat adults with bacterial skin and skin structure infections. Among them are infections caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes.
Dalvance is the first drug designated as a Qualified Infectious Disease Product to receive FDA approval. It was given this label under the Generating Antibiotic Incentives Now (GAIN) portion of the FDA Safety and Innovation Act and thereby given priority review.
“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,” 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.
The treatment is administered intravenously. There have been two clinical trials with 1,289 adults with ABSSI. Dalvance is marketed by Chicago-based Durata Therapeutics.