(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
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