Durata Therapeutics has submitted an MAA to the EMA for dalbavancin, for the treatment of patients with complicated skin and soft tissue infections (cSSTI) caused by susceptible Gram-positive microorganisms, including Staphylococcus aureus (including methicillin-resistant strains) and Streptococcus pyogenes, as well as certain other streptococcal species. Following the standard EMA review cycle timing, the company anticipates a decision in 1H15.

If approved, dalbavancin will be the first drug for cSSTI with once-weekly dosing given in a short, 30-minute IV infusion time, which may help reduce the overall burden of care without sacrificing patient outcome, according to the company.

The submission included results from the two Phase III trials, DISCOVER 1 and DISCOVER 2, as well as a previous Phase III study (VER001-9). In the DISCOVER trials, cSSTI was defined as cellulitis, wound infection, or major cutaneous abscess with an associated area of surface erythema measuring at least 75 cm2 accompanied by at least two other local signs of infection and at least one of the following systemic signs of infection: fever, leukocytosis, or increased immature neutrophils.

The EMA submission follows the FDA’s acceptance for priority review of the NDA for Dalvance (dalbavancin hydrochloride). That NDA has an action date of May 26, 2014.

Dalbavancin is a second generation, semi-synthetic lipoglycopeptide, which consists of lipophilic side-chains attached to glycopeptides. When compared to vancomycin, dalbavancin has a longer half-life resulting in a duration of antibacterial activity of five to seven days per dose.