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Cubist's treatment for skin infections OK'd.

WASHINGTON -- The Food and Drug Administration has approved a new drug to treat acute bacterial skin infections.

The drug, Sivextro (Cubist Pharmaceuticals Inc.), is designed to treat serious acute bacterial skin and skin structure infections, or ABSSSI. These are infections that involve deep tissue or are associated with an underlying disease such as diabetes.

Approval of Sivextro, known also as tedizolid, comes in the aftermath of regulatory clearance of the drug Dalvance for the same condition and manufactured by Durata Therapeutics Inc.

The drugs target Gram-positive infections, including methicillin-resistant Staphylococcus aureus, or MRSA. Sivextro is given once daily for six days. Dalvance is administered in two doses, separated by eight days.

The main treatment for MRSA is vancomycin, which is available genetically.

Sivextro received an expedited review by the FDA and was designated a qualified infectious disease product, meaning it qualifies for an extra five years of marketing exclusivity.

"We are pleased by the FDA approval of Sivextro, which provides a new option for physicians to treat patients with serious bacterial skin infections, including those caused by MRSA," said Michael Bonney, chief executive officer of Cubist.

"Sivextro provides physicians with flexibility to transition patients from I.V. to oral treatment as required. The oral option provides opportunity for out-patient care, which could reduce the need for costly hospitalization.

"In addition, Sivextro is one of at least four antibiotics Cubist hopes to deliver in support of the Infectious Diseases Society of America challenge to industry and policy makers to develop and approve 10 new antibiotics by 2020."

MRSA is still problematic in the United States, and it is responsible for the deaths of more than 11,000 Americans every year.

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Title Annotation:RX/Branded Drugs
Publication:Chain Drug Review
Date:Jul 7, 2014
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