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FDA puts new antibiotic on fast track
Infection Control Monitor, April 1, 2005
The Food and Drug Administration (FDA) has placed Theravance, Inc.'s, new antibiotic, Telavancin, on fast-track status to speed up the development of the drug, which will help in the treatment of hospital-acquired pneumonia (HAP) and complicated skin and skin structure infections (cSSSI).
The FDA's fast-track program expedites the review of new drugs to be used in the treatment of serious or life-threatening conditions.
Theravance believes the drug is capable of speeding bacterial killing and reducing the risk of inducing resistance.
In the cases of HAP and cSSSI, Telavancin has the potential to address an unmet medical need because of its in vitro activity against Staphylococcus aureus, as well as methicillin-resistant and vancomycin-tolerant strains.
Currently, the FDA is evaluating Telavancin in phase III studies for the treatment of HAP and cSSSI.
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