FDA Approves Durata Drug to Treat Acute Skin Infections

The Food and Drug Administration announced Friday announced that it has approved Durata Therapeutics' drug Dalvance (dalbavancin) that treats skin infections.

Dalvance is an anti-microbial drug and is to be used by adults with certain bacterial infections called acute bacterial skin and skin structure infections or ABSSSI. The drug is injected intravenously, FDA said in a press statement.

Over 4 million hospital visits between 2005 and 2011 were associated with ABSSSI. Streptococci and Staphylococcus aureus are the main causes for infections and around 59 percent of these infections are caused by Methicillin-resistant Staphylococcus aureus (MRSA).

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

Dalvance is the first drug designated as a Qualified Infectious Disease Product because it is to be used by adults with serious, life-threatening infections, FDA said.

The Chicago-based company - Durata - said that the drug will provide doctors with more options to treat the infection.

The drug will be given in two doses; first on day one and the second on day eight, Reuters reported.

"DALVANCE's unique dosage regimen offers a new approach to treatment of these serious skin infections by allowing patients, health care professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions," said Paul Edick, Chief Executive Officer of Durata Therapeutics, according to a news release. 

Safety and efficacy of the new drug was tested during two clinical trials that included a total of 1,289 adults with the condition. Participants were randomly given either the test drug or vancomycin, which is another anti-bacterial drug. Study results showed that Dalvance was as effective as vancomycin in treating the infection.

Diarrhea, headache and nausea are some of the common side-effects of using the drug, the federal agency said.