BioCentury
ARTICLE | Clinical News

Dalvance dalbavancin: Phase IIIb started

May 5, 2014 7:00 AM UTC

Durata began a double-blind, international Phase IIIb trial to compare a single 1,500 mg dose of IV Dalvance vs. 1,000 mg IV Dalvance given on day 1 followed by a 500 mg dose on day 8 in about 410 adults with ABSSSI caused by Gram-positive bacteria. The company said the trial is designed to meet new standards required by regulatory authorities for antibiotic development in the U.S. The 2-dose regimen of Dalvance is under FDA Priority Review, with a May 26 PDUFA date. In March, FDA's Anti-Infective Drugs Advisory Committee voted 12-0 in favor of approval of Dalvance (see BioCentury, April 7). Dalbavancin is also under EMA review to treat complicated skin and soft tissue infections (cSSTI) caused by susceptible Gram-positive microorganisms. ...