FDA Committee Recommends Durata's Dalvance For Skin Infections

Durata Therapeutics, Inc. announced in a press release that a Food and Drug Administration (FDA) committee has recommended Dalvance (dalbavancin). The Anti-Infective Drugs Advisory Committee indicated in a unanimous 12-0 vote that evidence of safety and effectiveness was sufficient. The investigational antibiotic drug is administered by injection to adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).

The federal agency is not bound by the committee’s recommendation but it gives serious weight to its decision. The FDA will consider Durata’s New Drug Application (NDA) and is expected to make a decision by May 26, 2014. Paul R. 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.”

Acute Bacterial Skin and Skin Structure Infections

Acute bacterial skin and skin structure infections (ABSSSI) are serious infections most often caused by Staphylococcus aureus and MRSA (methicillin-resistant Staphylococcus aureus). About 17 percent of the 9.2 million patients with infections in the U.S. from the period of January to June 2010 were for skin and skin structure infections (SSSIs). Of that 17 percent, 74 percent were from ABSSSI. Treatment consists of early detection and treatment to avoid surgery, wound expansion, costly hospital stays, and increased risk of infection while in the hospital.

Dalvance

Dalvance (dalbavancin) was first introduced to the FDA when Vicuron Pharmaceuticals, Inc. applied for an NDA in 2004. Pfizer acquired the drug in September 2005 during the acquisition of Vicuron in 2005. FDA regulators were unconvinced of its promise and Pfizer sold the drug to Durata, which will owe Pfizer milestone payments if the drug earns regulatory approval in the U.S. and Europe.

Dalvance is a synthetic lipoglycopeptide — a class of antibiotics that have lipophilic side-chains attached to glycopeptides. The drug has undergone 21 clinical trials including Phase 3 trials with 3,000 patients. The DISCOVER 1 and DISCOVER 2 Phase 3 trials included 1,300 patients with ABSSSI. Patients took dalbavancin or vancomycin intravenously. Investigators found that dalbavancin stopped the spread of the erythema (redness) and resolved fever.