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Sivextro is second antibiotic OK'd by FDA for acute skin infections


By Steven Ross Johnson
Posted: June 20, 2014 - 7:45 pm ET
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Federal regulators have approved a new antibiotic drug intended for use against antimicrobial-resistant skin infections.

The Food and Drug Administration late Friday announced it has approved for sale the drug Sivextro, produced by Massachusetts-based drugmaker Cubist Pharmaceuticals, for the treatment of patients with acute skin and soft tissue infections from methicillin-resistant strains of bacteria such as MRSA.

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The drug is intended to be given for a period of six days, with patients initially receiving the antibiotic intravenously in a hospital setting for about two days and then switching to an oral treatment of one pill per day that could be taken at home depending on how their condition progresses, according to Steven Gilman, Cubist executive vice president and chief scientific officer, who spoke with Modern Healthcare Thursday in anticipation of Sivextro receiving FDA approval.

Sivextro is the second antibiotic the FDA has approved in the past month to treat acute skin infections. The first was Dalvance, which regulators approved May 23. It was the first to be designated as a qualified infectious disease product, or QIDP, under the Generating Antibiotic Incentives Now Act of 2012. The designation is granted to antibacterial and antifungal drugs intended to treat serious or life-threatening infections.

Like Dalvance, Sivextro also has been designated a QIDP, which allowed it to receive an expedited review and will also give Cubist an additional five years of marketing exclusivity. Such benefits are part of a concerted effort on the part of the federal government to provide more financial incentives for pharmaceutical firms to invest in the research and development of new antibiotic drugs.

“Today’s approval provides physicians and patients with a new treatment option for serious skin infections,” said Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, in a written statement.

The dearth of antibiotics in the development pipeline has been a major concern of health experts and public-health officials for years in light of the growing numbers of antibiotic-resistant pathogens identified over the past decade.

Ongoing analysis being conducted by the Pew Charitable Trusts has found at least 45 antibiotics in various stages of development as of February. But the same analysis estimated only 1 in 5 would make it through the development and testing stages to get FDA approval.

Follow Steven Ross Johnson on Twitter: @MHsjohnson


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