FDA advisory unanimously recommends Durata’s Dalvance

The US Food and Drug Anti-Infective Drugs Advisory Committee voted 12 to 0 that Durata Therapeutics’ (Nasdaq: DRTX) has provided substantial evidence of the safety and effectiveness of its investigational drug, Dalvance (dalbavancin) for injection, for the panel to recommend approval of the drug. The firm’s shares jumped 5% to $14.15 on the news.

The advisory panel recommended Dalvance be approved for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). The same Committee also approved Cubist’s Sivextro (see separate story).

While not bound by the guidance provided by the Committee, the FDA will consider the Committee's deliberations as part of its review of the New Drug Application for Dalvance, which was accepted for priority review by the FDA in November 2013 with an action date of May 26, 2014.