The US Food and Drug Administration has given the green light to Durata Therapeutics' Dalvance, an antibacterial for skin infections.

Specifically, Dalvance (dalbavancin) has been approved to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The treatment, which is administered intravenously, is the first drug designated as a 'qualified infectious disease product' (an antibacterial or antifungal intended to treat serious or life-threatening infections) to receive FDA approval.

As part of its QIDP status, Dalvance was given priority review and it also qualifies for an additional five years of marketing exclusivity. The approval is based on two trials with a total of 1,289 adults with ABSSSI and the results showed Dalvance was as effective as the current gold standard of treatment, vancomycin.

Dalvance is the only IV antibiotic approved for ABSSSI with a two-dose regimen of 1000mg followed one week later by 500 mg, each administered over 30 minutes. Durata chief executive Paul Edick said that this unique dosage regimen offers a new approach to treatment of these serious skin infections, beyond the standard daily or twice-daily IV antibiotic infusions.

He added that "the time to build out and train a first-class salesforce, complete packaging and final qualification activities keeps us on track to begin shipping in the third quarter".

Dalvance was recommended for approval by the FDA's Anti-Infective Drugs Advisory Committee at the end of March, as was Cubist Pharmaceuticals' antibacterial Sivextro (tedizolid). The latter is also expected to be approved shortly.