Durata: EMA Accepts Marketing Authorization Application For Dalbavancin

(RTTNews) - Durata Therapeutics Inc. (DRTX) said the European Medicines Agency or EMA has accepted for review a Marketing Authorization Application or MAA for dalbavancin. Durata is seeking approval for the marketing and sale of dalbavancin to treat patients with complicated skin and soft tissue infections or cSSTI caused by susceptible Gram-positive microorganisms, including Staphylococcus aureus and Streptococcus pyogenes, as well as certain other streptococcal species. The review procedure begins on December 26, 2013, and the firm expects a decision in the first half of 2015.

Dalbavancin is a second generation, semi-synthetic lipoglycopeptide, which consists of lipophilic side-chains attached to glycopeptides.

The company's Chief Executive noted, "We are pleased the EMA has accepted our marketing authorization application submission for a potential new treatment option for patients with cSSTI. If approved, dalbavancin will be the first drug for cSSTI with unique 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."

The submission, announced on December 3, 2013, comprised results from the two Phase 3 trials, DISCOVER 1 and DISCOVER 2, as well as a previous Phase 3 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 acceptance follows the US Food and Drug Administration or FDA's acceptance for priority review of the New Drug Application for Dalvance with an action date of May 26, 2014.