The US Food and Drug Administration gave its nod to Dalvance (dalbavancin), a new antibacterial drug for adults with skin infections.
Dalvance is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. The treatment is given intravenously once a week. Dalvance is marketed by Chicago-based Durata Therapeutics.
Dalvance is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now title of the FDA Safety and Innovation Act, Dalvance was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections. As part of its QIDP designation, Dalvance was given priority review, which provides an expedited review of the drug’s application.
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. Results showed Dalvance was as effective as vancomycin for the treatment of ABSSSI. The most common side effects were nausea, headache, and diarrhea. In the trials, more participants in the Dalvance group had elevations in one of their liver enzyme tests. The Dalvance drug label provides recommendations on dosage adjustment in patients with renal impairment.