Dalbavancin is a novel second-generation lipoglycopeptide agent designed by Vicuron Pharmaceuticals, which belongs to the same class as vancomycin, the most widely-used and one of the few treatments available to patients infected with the most difficult-to- treat strains of Staphylococcus (Staph): MRSA (methicillin-resistant Staphylococcus aureus) and MRSE (methicillin-resistant Staphylococcus epidermidis). Dalbavancin has been particularly designed as an improved alternative to vancomycin. In vitro studies have shown that in addition to being potent against clinically significant Gram-positive bacteria, it is bactericidal (i.e., kills bacteria rather than merely inhibiting their growth). The potency, tissue penetration and half-life of dalbavancin may allow for more flexible and convenient dosing regimens than vancomycin. In preclinical and clinical studies to date, dalbavancin appears to be the most potent antibiotics in its class against MRSA and MRSE. This drug is developed by

With the increase of infections caused by Gram-positive bacteria, dalbavancin will offer a potent alternative to older agents such as vancomycin. In addition, two doses of dalbavancin in complicated skin infections in place of other antibiotics requiring up to 28 doses can potentially alter the course of treatment for this serious disease.

The NDA includes results from more than 1,850 subjects and three Phase 3 trials, which evaluated the safety and efficacy of dalbavancin in patients with SSTIs caused by Gram-positive bacteria. The Phase 3 clinical trials met the primary and secondary endpoints of non-inferiority when compared to linezolid, cefazolin or vancomycin -- three commonly used standard-of-care agents for SSTIs. The vast majority of the patients treated in these studies had SSTIs caused by Staph aureus bacteria, with more than 400 patients infected with methicillin-resistant Staph aureus (MRSA), one of the most difficult-to-treat strains of bacteria.