U.S. FDA approves Durata's acute bacterial skin infection drug

WASHINGTON Fri May 23, 2014 4:58pm EDT

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WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday it has approved a new drug to treat acute bacterial skin infections made by Durata Therapeutics Inc.

Approval of the drug, Dalvance, follows a positive recommendation by the FDA's advisory committee, which also gave a favorable review to a rival product from Cubist Pharmaceuticals Inc. The FDA is set to rule on the Cubist drug shortly.

Both drugs are designed to treat serious acute bacterial skin and skin structure infections, or ABSSSI. The infections involve deep tissue or are associated with an underlying disease such as diabetes. They are aimed at serious Gram-positive infections, including methicillin-resistant Staphylococcus aureus, or MRSA.

Durata's drug, known generically as dalbavancin, is given in two doses, the first on day one and the second on day eight.

"Dalvance's unique dosage regimen offers a new approach to treatment of these serious skin infections by allowing patients, health care professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions," Paul Edick, Durata's chief executive, said in a statement.

Edick said the company is "executing on all fronts" to prepare for the launch of the drug, and said he expects the company to begin shipping the product in the third quarter.

Dalvance is expected to generate annual sales of about $446 million by 2019 according to Thomson Reuters data. Durata's shares closed up 5.5 percent at $16.89.

Clinical trials of the drug showed Dalvance was not inferior to a control arm that included vancomycin, a treatment that is available generically, or vancomycin followed by Pfizer Inc's linezolid, which is sold under the brand Zyvox.

(Reporting by Toni Clarke in Washington; Editing by Chizu Nomiyama; Editing by Chizu Nomiyama)

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