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NEW DRUG DEVELOPMENTS

Dalbavancin: A New Option for the Treatment of Gram-Positive Infections

at time of writing, Specialty Resident in Infectious Diseases, Department of Pharmacy Services, University of Michigan Health System; Clinical Instructor, Department of Clinical Sciences, College of Pharmacy, University of Michigan, Ann Arbor, MI; now, Clinical Pharmacist, Infectious Diseases, Department of Pharmacy Services, Hahnemann University Hospital, Philadelphia, PA

Peggy L Carver, PharmD

Clinical Pharmacist in Infectious Diseases, Department of Pharmacy Services, University of Michigan Health System; Associate Professor, Department of Clinical Sciences, College of Pharmacy, University of Michigan

Daryl D DePestel, PharmD

Clinical Pharmacist in Infectious Diseases, Department of Pharmacy Services, University of Michigan Health System; Clinical Assistant Professor, Department of Clinical Sciences, College of Pharmacy, University of Michigan

Reprints: Dr. DePestel, Departments of Pharmacy Services and Clinical Sciences, University of Michigan Health System, UH B2D 301/0008, 1500 E. Medical Center Dr., Ann Arbor, MI 48109-0008, fax 734/936-7027, daryldd{at}umich.edu

OBJECTIVE: To review the pharmacology, microbiology, chemistry, in vitro susceptibility, pharmacokinetics, clinical efficacy, safety, tolerability, dosage, and administration of dalbavancin, a new semisynthetic lipoglycopeptide.

DATA SOURCES: A MEDLINE search, restricted to the English language, was conducted from 1966 through January 2006. Supplementary sources included program abstracts from the Interscience Conference on Antimicrobial Agents and Chemotherapy, American Society of Microbiology, and the Infectious Diseases Society of America from 2000 to 2005 and information available from the manufacturer's Web site.

STUDY SELECTION AND DATA EXTRACTION: In vitro and preclinical studies, as well as Phase I, II, and III clinical trials, were evaluated to summarize the microbiology, pharmacology, clinical efficacy, and safety of dalbavancin. All published trials and abstracts citing dalbavancin were selected.

DATA SYNTHESIS: Dalbavancin, a novel lipoglycopeptide, has a mechanism of action similar to that of other glycopeptides. It has in vitro activity against a variety of gram-positive organisms, but no activity against gram-negative or vancomycin-resistant enterococci that possess VanA gene. Due to its prolonged half-life (6-10 days), dalbavancin can be administered intravenously once weekly. In Phase II and III clinical trials, dalbavancin was effective and well tolerated for the treatment of skin and soft-tissue infections, catheter-related bloodstream infections, and skin and skin-structure infections. To date, adverse events are mild and limited; the most common include pyrexia, headache, nausea, oral candidiasis, diarrhea, and constipation.

CONCLUSIONS: Dalbavancin appears to be a promising antimicrobial agent for the treatment of gram-positive infections. A new drug application was filed with the Food and Drug Administration (FDA) in December 2004. The FDA issued an approvable letter in 2005 for dalbavancin. If approved, dalbavancin is expected to be launched in the first quarter of 2006.

Key Words: BI397, dalbavancin, glycopeptide, gram-positive

Published Online, February 28, 2006. www.theannals.com, DOI 10.1345/aph.1G158

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