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Theravance antibiotic fast tracked by FDA

Theravance Inc's investigational antibiotic, telavancin, has been granted fast track status by the FDA for the treatment of hospital-acquired pneumonia and complicated skin and skin structure infections.

The fast track programs of the FDA are designed to facilitate the development and expedite the review of new drugs intended for serious or life-threatening conditions and demonstrating the potential to address unmet medical needs.

Telavancin has the potential to provide alternative therapy for hospital-acquired pneumonia (HAP) and complicated skin and skin structure infections (cSSSI)and to address an unmet medical need because of its in vitro activity against Staphylococcus aureus, including methicillin-resistant and vancomycin-tolerant strains.

Telavancin, a rapidly bactericidal injectable antibiotic, is a novel lipoglycopeptide that was discovered by Theravance through the application of multivalent drug design. Previously presented data demonstrated that telavancin has a unique multifunctional mechanism of action that the company believes speeds bacterial killing and reduces the risks of inducing resistance.

Telavancin is currently being evaluated in phase III studies for the treatment of HAP and cSSSI.