The drug's designation as a Qualified Infectious Disease Product gave it fast track review and qualifies it for an extra five years of market exclusivity, on top of any other exclusivity period it might normally enjoy.
Dalvance was tested in two clinical trials that consisted of 1,289 adults with skin infections and found to be as effective as vancomycin, another powerful antibiotic. Side effects include nausea, headache, diarrhea and elevated levels of a liver enzyme. It is administered in two intravenous doses and the manufacturer, Durata Therapeutics, has not yet provided price information. The FDA approved the drug on May 23.
The World Health Organization is so concerned about the spread of antibiotic-resistant superbugs that it said in April: “The problem is so serious that it threatens the achievements of modern medicine.” The organization said that the 21st century could see a "post-antibiotic era" when standard treatments no longer work and common infections, once easily controlled, are lethal.
The U.S. Centers for Disease Control and Prevention said in March that one in 25 patients will acquire infections, including MRSA, in hospitals or other health-care facilities, and that more than 200 people die from those infections every day.
According to Durata, more than 4.8 million people were admitted to hospitals with skin and soft tissue infections between 2005 and 2011. The majority of them were caused by Streptococcus and Staphylococcus aureus bacteria, and approximately 59 percent of the staph infections were the methicillin-resistant variety.