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(Updates with details from panel meeting)
March 31 Durata Therapeutics Inc's drug to treat acute bacterial skin infections shows substantial evidence of safety and efficacy, a panel of advisers to the U.S. Food and Drug Administration concluded on Monday.
The panel voted unanimously in favor of the drug, dalbavancin, paving the way for its approval. The FDA is not obliged to follow the advice of its expert panels but typically does so.
The intravenous drug, which would be sold under the brand name Dalvance if approved, is designed to be given in two doses, the first on day one and the second on day eight. The latest clinical trials were designed to show the drug was not inferior, in terms of efficacy, to a control arm that included vancomycin or vancomycin followed by Pfizer Inc's linezolid, which is sold under the brand Zyvox.
Panelists said they had some concerns about the potential for the drug to cause liver problems, especially in patients with underlying liver disease, and recommended the company be required to conduct additional safety studies once the drug is on the market.
They also urged the FDA to work with the company to develop guidelines for patient follow-up after the initial dose has been given to ensure patients receive the critical second dose.
"I'm wondering how many people will get a shot of this, go out the door and never come back," said Dr. Michael Neely, a panelist and associate professor of pediatrics at the University of Southern California.
The panel also gave a positive review of Cubist Pharmaceuticals Inc's anti-infective tedizolid for acute bacterial skin infections. (Reporting by Toni Clarke in Washington; Editing by Peter Cooney)