The FDA has approved oritavancin (Orbactiv), an intravenous (IV) antibacterial drug, to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant Staphylococcus aureus
(MRSA), various Streptococcus
species, Enterococcus faecalis
, and other certain susceptible bacteria.
Orbactiv was formerly granted a Qualified Infectious Disease Product (QIDP) designation under the Generating Antibiotic Incentives Now title of the FDA Safety and Innovation Act, because it is “an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection,” the agency said
. As a QIDP medication, Orbactiv received an expedited application review by the FDA and now qualifies for an additional 5 years of marketing exclusivity.
In a statement
, Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company, the manufacturer of the drug, said the approval of Orbactiv “represents an important advance beyond the current standard of care for bacterial skin and skin structure infections.”
Orbactiv’s approval was based on results from a pair of clinical trials in which nearly 2000 adults with ABSSSI were randomly assigned to receive either Orbactiv or Vancomycin (Vancocin). Results from both studies showed Orbactiv was just as effective as vancomycin in treating ABSSSI, as The Medicines Company said the trials “demonstrated non-inferiority for the primary and secondary endpoints evaluating 1200 mg once-only IV Orbactiv dose infusion, versus 7 to 10 days of twice-daily vancomycin (1 g or 15 mg/kg).”
The most common side effects reported in the 2 trials included headache, nausea, vomiting, diarrhea, and the formation of skin and soft tissue abscesses on arms and legs. Orbactiv’s approved label also contains a warning regarding interference with coagulation tests and interaction with warfarin, a drug used to prevent blood clots.
“The growing challenge of antibiotic resistance in the US has had a significant impact on the clinical management decisions in the emergency department,” said Charles Pollack, MD, Chair of the Department of Emergency Medicine at Pennsylvania Hospital and Professor of Emergency Medicine at the Perelman School of Medicine at the University of Pennsylvania, in the statement. “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.”