FDA OKs Oritavancin (Orbactiv) for Skin Infections

Megan Brooks

Disclosures

August 07, 2014

Maintaining its focus on overcoming antibiotic resistance, the US Food and Drug Administration (FDA) has approved another new antibiotic for skin infections.

Oritavancin (Orbactiv, The Medicines Co) is indicated to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, such as Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species, and Enterococcus faecalis, the FDA announced yesterday.

Oritavancin, which is administered intravenously, is the third new antibacterial drug approved by the FDA this year to treat ABSSSI.

The agency approved dalbavancin (Dalvance, Durata Therapeutics) in May and tedizolid (Sivextro, Cubist Pharmaceuticals) 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," Edward Cox, MD, PhD, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in a statement.

"However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs," he added.

The FDA said oritavancin's safety and efficacy were demonstrated in 2 clinical trials involving 1987 adults with ABSSSI who were randomly assigned to oritavancin or vancomycin. Oritavancin proved as effective as vancomycin for the treatment of ABSSSI.

The most common adverse events were headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs, and diarrhea. The drug's label also includes a warning regarding interference with coagulation tests and interaction with warfarin, the FDA said.

Oritavancin is the third new drug designated as a Qualified Infectious Disease Product to receive FDA approval. The drug was granted this designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections.

This regulatory status entitled oritavancin to a fast-track application review. The drug also will receive an additional 5 years of marketing exclusivity under the Qualified Infectious Disease Product designation.

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