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FDA advisory committee finds dalbavancin safe, effective for ABSSSI
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The FDA Anti-Infective Drugs Advisory Committee has voted unanimously that dalbavancin has demonstrated substantial effectiveness and safety for the treatment of acute bacterial skin and skin structure infections caused by certain gram-positive organisms, including staphylococci and streptococci.
In October 2012, dalbavancin (Durata Therapeutics) was designated as a Qualified Infectious Disease Product under the Generating Antibiotic Incentives Now (GAIN) Act, because of its ability to treat MRSA.
“This is one example of trying to see homogeneity in the trial population and a single result, when in reality, in clinical practice, it’s just the opposite,” committee member Alan Magill, MD, of the Bill and Melinda Gates Foundation, told the panel. “This is the ultimate personalized medicine. What we’ve seen today is a variety of options in terms of dosing and regimens for ABSSSI. This gives physicians a lot of tools in the toolbox.”
The committee’s decision was based on three phase-3 studies. In two randomized, double-blind studies, patients received IV dalbavancin on day 1 and day 8, or 3 days of IV vancomycin with the option switch to oral linezolid (Zyvox, Pfizer) after completing treatment. In the third study, the researchers compared dalbavancin to linezolid.
The committee members advised against using the drug in the pediatric population until further studies are complete. They also stressed the importance of monitoring liver function tests, especially among those with underlying liver disease.
Addressing concerns raised in the open public hearing about noninferiority trials, committee member Thomas Moore, MD, of the University of Kansas, said that noninferiority trials are important when you’re considering treating a condition that is potentially fatal, for which there are other various medications available.
Committee member Bernhard Wiedermann, MD, of Children’s National Medical Center, concurred and said that noninferiority trials undergo extra scrutiny.
“My general rule with noninferiority studies is to be 10 times more vigilant in trying to find fault compared to superiority studies because there are more pitfalls with noninferiority studies,” Wiedermann said.