FDA Approves Orbactiv to Treat Skin Infections in Adults

The FDA has approved Orbactiv (oritavancin), an intravenously administered antibacterial drug, to treat patients “with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis.”

Orbactiv has been designated as a Qualified Infectious Disease Product (QIDP) 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.”

As a QIDP medication, Orbactiv received a priority, expedited review by the FDA and also qualifies for an additional five years of marketing exclusivity.

In a statement, Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company (which markets 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 was approved based on results from two clinical trials in which nearly 2,000 adults with ABSSSI were randomly assigned to receive Orbactiv or vancomycin. According to the FDA approval announcement, trial results showed Orbactiv was “as effective as vancomycin for the treatment of ABSSSI.”

The clinical trials (SOLO I and SOLO II) evaluated a single 1200 mg dose of Orbactiv for the treatment of ABSSSI. The study cohort also included a subset of 405 patients with MRSA infection. According to The Medicines Company, these 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 by investigators in the two trials were headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs and diarrhea. Orbactiv’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin, a drug used to prevent blood clots.

Charles Pollack, MD, Chair, Department of Emergency Medicine, Pennsylvania Hospital and Professor of Emergency Medicine at the Perelman School of Medicine at the University of Pennsylvania, said in a statement that “the growing challenge of antibiotic resistance in the US 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.”