Orbactiv is an intravenously administered drug indicated for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) resulting from Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species, and Enterococcus faecalis among others.
The drug was the third designated by the FDA as Qualified Infectious Disease Product (QIDP) to receive approval. Orbactiv was given priority review and an extra five years of marketing exclusivity aside from the regular exclusivity period established by the FDA.
Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said that the approvals of the new antibacterial drugs increase the availability of treatment options for bacterial infections.
“ORBACTIV given as a single dose treatment is a welcome new development for the treatment of skin infections. With a single dose treatment regimen ORBACTIV may help reduce the dosing burden seen with antibiotics given as multiple intravenous administrations to patients with these infections,” said G. Ralph Corey, Professor of Medicine and Infectious Diseases at Duke University.
Professor Charles Pollack, Chair of the Department of Emergency Medicine in Pennsylvania Hospital, said, “The growing challenge of antibiotic resistance in the U.S. has had a significant impact on the clinical management decisions in the emergency department. A single, once-only IV therapy such as ORBACTIV offers the option to administer a single treatment in the outpatient setting for patients with skin infections caused by Gram-positive bacteria likely due to MRSA.”
Orbactiv’s approval was supported by positive safety and efficacy results from two clinical trials showing the drug’s on par performance with Vancomycin for the treatment of ABSSSI. In addition, the European Medicines Agency (EMA) has accepted for review Orbactiv’s Marketing Authorization Application. The Medicines Company expects a decision during the first half of 2015.