Durata's Dalvance Receives Positive Opinion From FDA Panel

Durata Therapeutics announced that its investigational drug Dalvance for serious skin infections has received positive recommendation for approval from the U.S. Food and Drug Administration's (FDA) Anti-Infective Drugs Advisory Committee (AIDAC).

The panel voted 12 – 0 in favor of the approval of Dalvance for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The recommendation was based on substantial supporting information establishing the safety and effectiveness of Dalvance.

Paul Edick, Durata Therapeutics CEO, said, “We are pleased with the positive outcome of today's Advisory Committee meeting, and the confidence that was expressed regarding the safety and effectiveness of Dalvance. If approved by the FDA, Dalvance would be the first once-weekly antibiotic for ABSSSI, providing an alternative to current once- or twice-daily treatments. We look forward to continuing to work with the FDA on its evaluation of our product.”

Acute bacterial skin and skin structure infections (ABSSSI) increased by 176 percent from 1997 to 2009 in hospitalized patients. Majority of skin and soft tissue infections in patients in hospitals are caused by Staphylococcus aureus, and approximately 59 percent of these infections are caused by MRSA in the U.S. Effective early treatment is key to prevent wound expansion and to avoid costly and lengthy hospitalization. Failure to treat ABSSSI successfully may result in hospital readmissions.

Dalvance is a second generation, semi-synthetic lipoglycopeptide comprised of lipophilic side-chains attached to glycopeptides. The drug has demonstrated bacteriacidal activity in vitro against a wide range of bacteria including Streptococcus pyogenes and methicillin-resistant strains of Staphylococcus aureus.

While the FDA is not bound to follow the guidance provided by the AIDAC, the agency takes the Committee’s deliberations in consideration as part of its review of the NDA for Dalvance. The drug was accepted for priority review by the FDA in November 2013 and is expected to receive a decision on May 26, 2014.