The U.S. Food and Drugs Administration has approved a new antibacterial drug named Dalvance to treat skin infections among adults.
Dalvance is marketed by Chicago-based Durata Therapeutics and is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain vulnerable bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. The drug is given intravenously.
"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," said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in a press statement.
Dalvance is also the first Qualified Infectious Disease Product (QIDP) to receive approval from the FDA. The statement released by the FDA revealed that the drug was given a QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections. This designation also automatically qualifies the drug for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug and Cosmetic Act.
The effectiveness and safety of the drug was tested and proved in a clinical trial conducted on 1,289 adults with ABSSSI. Half the participants were given Dalvance while the other half were given vancomycin, another antibacterial drug. Researchers found that both the groups of participants benefited equally from both the drugs.
The side effects of the drug include nausea, headache and diarrhea. Researchers also found that the participants that were given Dalvance showed elevations in one of their liver enzyme test. The drug is marketed with a label that provides recommendations on dosage adjustment in patients with renal impairment.
"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," Paul Edick, Durata's chief executive said, according to Reuters.
The drug is expected to generate annual sales of about $446 million by 2019 according to the Reuters report.
