FDA Clears Dalbavancin (Dalvance) for Acute Skin Infections

Megan Brooks

Disclosures

May 23, 2014

The US Food and Drug Administration (FDA) has approved the antibacterial agent dalbavancin (Dalvance, Durata Therapeutics) for treatment of adults with skin infections, including methicillin-resistant Staphylococcus aureus (MRSA), the agency announced today.

Dalbavancin is a lipoglycopeptide antibacterial indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, such as S aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes, the FDA said.

The FDA's Anti-Infective Drugs Advisory Committee voted unanimously to recommend approval of dalbavancin on April 1, as reported by Medscape Medical News. The treatment is given intravenously.

"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, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

The drug's safety and efficacy were evaluated in 2 clinical trials involving a total of 1289 adults with ABSSSI. Results showed that dalbavancin was as effective as vancomycin for the treatment of ABSSSI, the FDA said.

The most common adverse effects identified in the participants in the clinical trials were nausea, headache, and diarrhea and elevations in 1 of their liver enzyme tests. The drug label for dalbavancin provides recommendations on dosage adjustment in patients with renal impairment, the FDA said.

Dalbavancin is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. The drug 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, dalbavancin was given priority review, which provides an expedited review of the drug's application. Dalbavancin's QIDP designation also qualifies it for an additional 5 years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug and Cosmetic Act, the FDA said.

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