Drug for MRSA infections to hit market

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The Food and Drug Administration has approved a medication for patients with acute bacterial skin and skin structure infections (ABSSSI) caused by bacteria that includes methicillin-resistant Staphylococcus aureus.

Dalvance, made by Durata Therapeutics, is the only intravenous antibiotic approved for ABSSSI. Close to 3,000 patients in 21 clinical trials were evaluated, and the medication was granted priority review as a Qualified Infectious Disease Product, in accordance with the Generating Antibiotics Incentives Now Act.

“Today's approval demonstrates the FDA's commitment to encouraging increased development and approval of new antibacterial drugs, providing physicians and patients with important new treatment options,” said Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research.

There were an estimated 4.8 million hospital admissions of adults with ABSSSI from 2005 through 2011, for problems such as cellulitis, erysipelas, wound infection and major cutaneous abscess, according to Durata. 

In a six-month period in 2010, out of a projected 9 million patients treated in hospitals for all types of infections, close to 17% were for skin and structure infections. Out of those, 74% were diseases categorized under ABSSSI.

Antibiotic-resistant infections are a continuing concern among the long-term care population.

Dalvance is a two-dose regimen of 1,000 mg followed one week later by 500 mg, each time administered over 30 minutes.

Its “unique dosage regimen offers a new approach to treatment of these serious skin infections by allowing patients, healthcare professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions,” Paul Edick, Durata Therapeutics CEO, said. “The time to build out and train a first-class sales force, complete packaging and final qualification activities keeps us on track to begin shipping in the third quarter.”


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