New Drug Dalvance Wins FDA Approval to Treat Skin Infections

A new antibacterial drug called Dalvance received the U.S. Food and Drug Administration nod to treat adults with skin infection.

In a latest announcement the federal regulators approved Dalbavancin (Dalvance), an antibacterial drug that cures acute bacterial skin and skin structure infections (ABSSSI) caused by bacteria Staphylococcus aurerus and Streptococcus Pyogenes.

"Today's approval demonstrates the FDA's commitment to encouraging increased development and approval of new antibacterial drugs, providing physicians and patients with important new treatment options," Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a press statement.

The newly approved drug is administered intravenously.  This is the first drug designated as a Qualified Infectious Disease Product (QIDP) to win the approval of the federal regulators.  The drug Dalvance was given the QIDP designation as this antibacterial or antifungal human drug is meant to treat serious or life-threatening infections.

As a part of the QIDP designation, the antibacterial drug Dalvance was given a priority review.  Apart from this, the QIDP designation also qualifies it for the next five years of marketing exclusivity.

The safety and efficacy of the drug was analyzed based on two clinical trials that were conducted on 1,289 adults with ABSSSI.  As a part of the test, the participants were randomly given either Dalvance or Vancomycin, another antibacterial drug.  The researchers noticed that compared to vancomycin, Dalvance was more effective in treating ABSSSI.

The participants reported side effects such as nausea, headache and diarrhea. During the trial, majority of the subjects from the group receiving Dalvance noticed a rise in one of their liver enzymes.  

The drug is marketed by Durata Therapeutics based in Chicago.