Durata Therapeutics (DRTX) received encouraging news when the U.S. Food and Drug Administration (FDA) approved its antibiotic DALVANCE (dalbavancin) for treating adults suffering from acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including MRSA (methicillin resistant staphylococcus aureus).
Durata stated in its press release that following the FDA nod, DALVANCE becomes the first intravenous antibiotic to be approved for treating ABSSSI. Approval has been gained for a two-dose regimen (once a week for two weeks).
The FDA’s favorable decision does not come as a surprise since in Mar 2014 its Anti-Infective Drugs Advisory Committee had unanimously (12-0) recommended DALVANCE‘s approval for the above indication based on the data submitted.
The FDA reviewed Durata’s marketing application, accepted in Nov 2013, on DALVANCE on a priority basis. We note that DALVANCE became eligible for priority review status following its qualified infectious disease product (QIDP) designation, granted by the FDA, for the ABSSSI indication. The QIDP designation is a part of the Generating Antibiotic Incentives Now (GAIN) Act, which falls under the 2012 FDA Safety and Innovation Act (FDASIA).
DALVANCE would compete with drugs like Teflaro. Competition in the ABSSSI market would intensify with the potential approval of Sivextro next month.
DALVANCE is under review in the EU in the complicated skin and soft tissue infections (cSSTI) indication. A decision is expected in the first half of 2015.
Durata currently carries a Zacks Rank #3 (Hold). Gilead Sciences (GILD) is a better-ranked stock in the healthcare space with a Zacks Rank #1 (Strong Buy).
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