The FDA has recently approved the antibacterial agent dalbavancin (Dalvance) for treatment of adult skin infections.
Dalvance, marketed by the Chicago-based Durata Therapeutics, is meant to treat acute bacterial skin and skin structure tissue infections caused by certain bacteria, such as Staphylococcus aureus and Streptococcus pyogenes. This would include methicillin-resistant Staphylococcus aureus (MRSA), the FDA announced.
Dalvance is the first drug classified as a Qualified Infectious Disease Product (QIDP) to gain approval from the FDA. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Dalvance was approved because it is an antifungal or antibacterial drug that seeks to cure life-threatening conditions.
“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.
Dalvance is a lipoglycopeptide and is delivered intravenously. It is given in only two 30-minute sessions. The first infusion is of 1,000 milligrams of the product, while the second infusion is of only 500 milligrams.
The FDA approval was ultimately based off of two clinical trails it performed. 1,289 adults participated in the trials, and each adult was either given dalbavancin or vancomycin. It was found that Dalvance was non-inferior to the older vancomycin.
The most common side effects of the drug during the trials were nausea, headaches and diarrhea. Some patients also showed signs of elevated liver enzymes. Patients with renal impairment may receive different doses due to their condition.
Currently, there are two other antibiotics aimed at combating acute bacterial skin and skin structure tissue infections pending FDA review. There is no telling whether or not they will be approved.