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December 3, 2013

Durata Therapeutics seeks European approval for dalbavancin

US-based pharmaceutical firm Durata Therapeutics has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval for the marketing and sale of dalbavancin to treat patients with complicated skin and soft tissue infections (cSSTI) caused by susceptible Gram-positive microorganisms.

By admin-demo

US-based pharmaceutical firm Durata Therapeutics has filed a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval for the marketing and sale of dalbavancin to treat patients with complicated skin and soft tissue infections (cSSTI) caused by susceptible Gram-positive microorganisms.

Gram-positive microorganisms include 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 expects a decision in the first half of 2015.

"With a long-acting, once weekly IV antibiotic treatment option, there may be a dramatic potential savings in terms of total cost of care when compared to daily IV antibiotic delivery."

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

If approved by the EMA, dalbavancin will be the first drug for cSSTI with two once-weekly 30-minute intravenous doses (1,000mg on day one and 500mg on day eight).

The drug is expected to reduce the overall cost of care for patients by shortening the duration of hospitalisation and enabling therapy in an outpatient setting for appropriate patients.

Durata Therapeutics chief executive officer Paul Edick said: "In the US, there is a focus on optimizing the location of treatment and clinical outcomes, as well as controlling the cost of IV antibiotic delivery.

"We believe a similar shift will take place in Europe in the next few years. With a long-acting, once weekly IV antibiotic treatment option, there may be a dramatic potential savings in terms of total cost of care when compared to daily IV antibiotic delivery."

The MAA is based on 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 studies, cSSTI was defined as cellulitis, wound infection, or major cutaneous abscess with an associated area of surface erythema measuring at least 75cm² 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 MAA filing to EMA follows the US FDA’s acceptance for priority review of the new drug application (NDA) for Dalvance (dalbavancin hydrochloride) with an action date of 26 May 2014.

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