MRSA-fighting drug is approved by FDA panel

Washington -- Of three new drugs in the pipeline for treating methicillin-resistant Staphylococcus aureus infections, only one received preliminary approval by a Food and Drug Administration advisory panel.

By a 21 to 5 vote Nov. 19, 2008, the Anti-Infective Drugs Advisory Committee decided that telavancin, a once-daily injectible drug, was safe and effective for combating skin and soft-tissue infections caused by gram-positive MRSA.

The FDA, which often accepts the advice of its panels, is expected within a few months to make a final decision on whether the drug should be marketed.

Approval was given despite some concerns raised about an increased risk of congenital anomalies.

Televancin acts by inhibiting the formation of the bacterial cell wall, thus disrupting the bacterial cell membrane function, according to the manufacturer.

The other two drugs, oritavancin and iclaprim, were not given the panel's go-ahead. Oritavancin was rebuffed by a 10 to 8 vote and iclaprim was more soundly rejected in a 17 to 2 vote. A lack of persuasive efficacy evidence was cited by the panelists.

The need for new antibiotics has become a pressing issue in medicine as bacteria become resistant to even the most powerful medications now available to physicians.

About 94,000 people in the U.S. developed a serious MRSA infection in 2005 and nearly 19,000 died, according to data reported in 2007 in the Journal of the American Medical Association.

Many of the hard-to-treat conditions are skin and soft-tissue infections, although, more rarely, bacteria can enter the bloodstream and become lethal.

"What we really, really need as clinicians is a potent anti-MRSA drug which is bactericidal and can be taken orally," said W. Michael Scheld, MD, professor of internal medicine at the University of Virginia and a former president of the Infectious Diseases Society of America. Dr. Scheld addressed the need for new medications at a news briefing during the October 2008 meeting of IDSA and the Interscience Conference on Antimicrobial Agents and Chemotherapy held in Washington, D.C.

Several poster sessions were presented at the meeting on new antibiotics in phase II and phase III clinical trials. For example, data were presented on PTK 0796, an oral and injectible antibiotic now in phase II trials. That drug represents a new class of antibiotics that appears to be potent against both gram-positive bacteria, including MRSA, and gram-negative bacteria, according to the manufacturer.