Durata’s antibiotic for skin infections OK’d by FDA

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A new antibiotic from Durata Therapeutics Inc. to treat adults with common skin infections often acquired in U.S. hospitals was approved Friday by the Food and Drug Administration.

Regulators approved the intravenous drug Dalvance to treat bacterial skin infections caused by common bacteria like Staphylococcus aureus, including antibiotic-resistant strains of those germs.

“We are proud to bring Dalvance to market for the millions of Americans who may benefit from an innovative treatment option for ABSSSI in today’s evolving health care environment,” said Paul Edick, chief executive officer of Chicago-based Durata Therapeutics.

Antibiotics like penicillin and streptomycin first became widely available in the 1940s, and today dozens are still used to kill or suppress the bacteria behind illnesses ranging from strep throat to the plague. The drugs are considered one of the greatest advances in the history of medicine, and have saved countless lives.

But as decades passed, some antibiotics stopped working against germs they previously eliminated. Experts say overuse and misuse of the drugs by physicians have made them less effective.

The FDA gave Dalvance an expedited review, under a 2012 law designed to encourage research and development of new antibiotics. Under the measure, Durata will receive an additional five years of exclusive marketing rights on the drug.

The FDA said it approved Dalvance based on two trials of nearly 1,300 patients with skin and skin structure infections. The studies showed that Dalvance, known generically as dalbavancin, was as effective as vancomycin, another antibiotic.

The Centers for Disease Control and Prevention estimated last year that the staph infection MRSA, or methicillin-resistant Staphylococcus aureus, kills about 11,000 people.

Durata’s stock ended Friday up 88 cents, or 5.5 percent, at $16.89.

The Associated Press

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