US regulators have approved The Medicines Company’s Orbactiv (oritavancin), a new intravenous antibacterial drug to treat adults with skin infections.
Orbactiv can now be used 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.
The move marks the third clearance of a new antibacterial drug by the US Food and Drug Administration this year for ABSSSI, having already given the nod to Durata’s Dalvance (dalbavancin) in May and Cubist’s Sivextro (tedizolid) in June.
“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,” noted Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs,” he stressed.
Orbactiv, which was given a Priority Review, is also the third new drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. This status comes under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, meant for antibacterial or antifungal human drugs intended to treat a serious or life-threatening infections. QIDP therapies get an additional five years of marketing exclusivity as an incentive for their development.
Safety and efficacy were assessed in two clinical trials involving 1,987 adults with ABSSSI, which showed the drug to be as effective as its comparator vancomycin, the FDA said. The most common side effects were ground to be headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs and diarrhea, and Orbactiv’s label also includes a warning regarding interference with coagulation tests and interaction with the bloodthinner warfarin.