Print“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, says Edward Cox, CDER.”
The U.S. Food and Drug Administration has approved Durata Therapeutics’ Dalvance, a new antibacterial drug administered intravenously to treat adults with acute skin and skin structure infections caused by susceptible gram-positive bacteria like Staphylococcus aureus, including methicillin-susceptible and methicillin-resistant strains such as MRSA, and Streptococcus pyogenes.
It is the first drug approved by the agency designated as a Qualified Infectious Disease Product under the Generating Antibiotic Incentives Now, or GAIN, act of the FDA Safety and Innovation Act. Dalvance was granted the designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections. As such it was given priority review and it will have an additional five years of marketing exclusivity.
“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,” says Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.
Dalvance’s safety and efficacy were evaluated in two clinical trials with a total of 1,289 adults with acute bacterial skin and skin structure infections. Participants were randomly assigned to receive Dalvance or vancomycin, another antibacterial drug. Results showed Dalvance was as effective as vancomycin for the treatment of acute bacterial skin and skin structure infections.
Durata acquired rights to the drug, known as dalbavancin, from Pfizer in December 2009 after Pfizer’s original submission to the FDA for marketing approval was rejected. It withdrew the submission in order to conduct another trial but instead sold the rights to Durata. Dalbavancin is a second-generation lipoglycopeptide in the same class of drugs as vancomycin and teicoplanin.
May 27, 2014
http://www.burrillreport.com/article-fda_approves_durata%e2%80%99s_dalvance_to_treat_skin_infections.html
