FDA approves oritavancin for skin infections

The FDA approved the antibacterial agent oritavancin, making it the third antibiotic approved in 2014 to treat skin infections, according to an agency press release.

Oritavancin (Orbactiv, The Medicines Company) is indicated for adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain pathogens, including MRSA and methicillin-susceptible Staphylococcus aureus, various Streptococcus species and Enterococcus faecalis. The drug is administered intravenously.

The FDA also approved dalbavancin (Dalvance, Durata Therapeutics) and tedizolid (Sivextro, Cubist Pharmaceuticals) earlier this year for the treatment of ABSSSIs.

“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, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the release. “However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs.”

Edward Cox

Oritavancin was designated as a qualified infectious disease product (QIDP), which is granted to antibacterial or antifungal agents intended to treat serious or life-threatening infections. QIDP status helped expedite oritavancin’s approval, and it gives The Medicines Company a 5-year extension of market exclusivity, according to the FDA.

The approval was based on results from two clinical trials with a total of 1,987 adult patients with ABSSSIs. Participants were randomly assigned to receive either oritavancin or vancomycin. Results indicated that oritavancin was as effective as vancomycin in treating the skin infections.

According to the FDA, the most common adverse effects observed in the clinical trials were headache, nausea, vomiting, the formation of skin and soft tissue abscesses on patients’ arms and legs, and diarrhea.