Vicuron’s investigational agent, dalbavancin, is a novel once-weekly antibiotic for the treatment of complicated skin and soft tissue infections (cSSTIs) including the most difficult to treat strain of staphylococcus, methicillin-resistant staphylococcus aureus (MRSA).
The FDA grants priority designation to products which, if approved, would be a significant improvement in the treatment of a disease.
“We are very pleased with this regulatory development which we believe further demonstrates the serious underserved medical need that dalbavancin has the potential to address,” said George Horner III, president and CEO of Vicuron. “We expect to commercialize dalbavancin by the first quarter of 2006 pending FDA approval.”
The new drug application (NDA), which was submitted in December 2004, includes results from more than 1,850 subjects and three phase III trials that evaluated the safety and efficacy of dalbavancin in patients with SSTIs caused by gram-positive bacteria.
The phase III clinical trials each met the primary and secondary endpoints of non-inferiority when compared to linezolid (Pfizer’s Zyvox), cefazolin (Eli Lilly’s Kefzol and GlaxoSmithKline’s Ancef) or vancomycin (Pfizer’s Vancocin), three currently used agents for SSTIs.