Orbactiv approved by FDA to treat serious bacterial skin infection in adults
Orbactiv was approved under the FDA Safety and Innovation Act's Generating Antibiotic Incentives Now (GAIN) provision, which was signed into law by President Obama in 2010.
Under the GAIN provision, drugs like Orbactiv that are designated as a "qualified infections disease product" designed to treat severe or life-threatening infection receive an expedited priority review by the FDA. The designation also grants an additional five years of marketing exclusivity for the drug to exclusivity periods already extended by the Food, Drug and Cosmetic Act.
Clinical trials evaluating the efficacy and safety of Orbactiv, which is marketed by The Medicines Company, showed the antibiotic was as effective as Vancocin (vancomycin) to treat bacterial skin infections.
The most common side effects associated with the drug included headache, nausea, vomiting, diarrhea and the formation of abscesses on the arms and legs.
The drug, which can treat infections caused by Staphylococcus aureus, Streptoccoccus and Enterococcus bacteria, is the third antibiotic to be approved by the FDA this year for the same purpose. The FDA recently approved Dalvance (dalbavancin) in May and Sivextro (tedizolid) in June.
According to a 2013 report from the Infectious Diseases Society of America (ISDA) only two new antibiotics, not including those approved this year, have been approved by the FDA since 2009.
"The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians," Edward Cox, the director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said. "However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs."