FDA Approves Orbactiv to Treat Severe Skin Infections

FDA has approved drug Orbactiv (oritavancin) for the treatment of skin infections.

The drug has been approved to treat acute bacterial skin and skin structure infections (ABSSSI) in adults. Orbactiv is for skin problems caused by Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis.

"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," said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, according to a news release. "However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs."

The newly-approved antibacterial drug is injected intravenously. The federal agency labelled the drug as Qualified Infectious Disease Product (QIDP) because Orbactiv is for serious, potentially life-threatening infections. The drug is marketed by The Medicines Company, based in Parsippany, N.J.

FDA evaluated the drug's safety and efficacy through two clinical trials of a total of 1,987 adults with ABSSSI. The participants were divided in two groups. One group received the test drug, while the other got vancomycin. The researchers found that Orbactiv was as effective as vancomycin for ABSSSI.

Common side-effects of the drug included nausea, headache, vomiting and development of small abscesses on hands and legs.

FDA said that the drug might interfere with some other medications, most notably warfarin, which is used to treat blood clots.

"Today's FDA approval of ORBACTIV represents an important advance beyond the current standard of care for bacterial skin and skin structure infections," said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company, according to a news release. "This approval is also a significant milestone for The Medicines Company as we continue to develop our infectious disease care portfolio. We are committed to addressing the complex problems associated with multi-drug resistant infections."

ABSSSI leads to hospitalization of 5.2 million patients in the United States and Western every year, Reuters reported.