FDA has approved oritavancin (Orbactiv, The Medicines Company
) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus
Orbactiv is the first and only antibiotic approved by FDA to treat ABSSSIs with a single, once-only administration. Once fully infused over 3 hours, the Orbactiv treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens.
Orbactiv is the third new antibacterial drug approved by FDA this year to treat ABSSSI. The agency approved dalbavancin (Dalvance
, Durata Therapeutics
) in May 2014 and tedizolid (Sivextro
, Cubist Pharmaceuticals
) in June 2014.
It is also the third new drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Orbactiv was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection.
As part of its QIDP designation, Orbactiv was given priority review, which provides an expedited review of the drug’s application. Orbactiv’s QIDP designation also qualifies it for an additional 5 years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug, and Cosmetic Act.
“The approval of Orbactiv adds another medication to the continuous growing arsenal of agents utilized in the treatment of ABSSSI,” said Clarence D. Moore, PharmD, BCSP, assistant professor, Howard University College of Pharmacy in Washington, D.C. “Orbactiv's unique single, once-only administration ensures that patients receive a complete treatment regimen without the burden of receiving multiple infusions for the management of ABSSSI. This attribute automatically improves patient compliance and potentially improves outcomes.”
Orbactiv’s approval is based on the results of the SOLO I and SOLO II clinical studies which were randomized, double-blind, multicenter trials that evaluated a single 1,200-mg IV dose of Orbactiv for the treatment of 1,987 adults with ABSSSI, and assessed a large subset of patients with documented MRSA infection (405 patients). These trials demonstrated non-inferiority for the primary and secondary end points evaluating 1,200 mg once-only IV Orbactiv dose infusion, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg).
Headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs and diarrhea were the most common side effects identified in the clinical trials. Orbactiv’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin.