Vicuron Pharmaceuticals Inc., a biopharmaceutical company, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for dalbavancin, a novel antibiotic for the treatment of complicated skin and soft tissue infections (cSSTIs). Dalbavancin is a unique, once weekly IV lipoglycopeptide for the treatment of cSSTIs caused by Gram-positive bacteria, including the most difficult-to-treat strains of Staphylococcus-methicillin-resistant Staphylococcus aureus (MRSA), a company release said.
"This is a major milestone for us as we move closer to bringing this promising antibiotic to the market," said George F. Horner III, president and CEO of Vicuron. "With the increase of infections caused by Gram-positive bacteria in the hospital, we believe 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 change 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 also 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.
"Given the promising benefits shown by this product, we believe dalbavancin represents an important achievement for both Vicuron and the hospital antibiotic category," added Horner.
Dalbavancin, a novel second-generation lipoglycopeptide agent, 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 specifically designed as an improved alternative to vancomycin. In vitro studies have shown that in addition to being potent against clinically important 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 one of the most potent antibiotics in its class against MRSA and MRSE.